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510(k) Number K841222 For BACTEROIDES BILE ESCULIN GAR From ANAEROBE SYSTEMS

Date Received: 1984-03-22

Decision Date: 1984-04-04

Contact:

Address:

City: McHenry

State: IL

Product Code: JSI

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Microbiology

Advisory Committee Code under which the product was classified: MI

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K841020 For FIBRINOGEN ASSAY KIT From HELENA LABORATORIES

Date Received: 1984-03-12

Decision Date: 1984-05-02

Contact:

Address:

City: McHenry

State: IL

Product Code: KQJ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Hematology

Advisory Committee Code under which the product was classified: HE

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840987 For VAPORIZED HEPARIN From CONCORD LABORATORIES, INC.

Date Received: 1984-03-07

Decision Date: 1984-04-05

Contact:

Address:

City: McHenry

State: IL

Product Code: CBT

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Anesthesiology

Advisory Committee Code under which the product was classified: CV

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840826 For TDX ETHANOL From ABBOTT LABORATORIES

Date Received: 1984-02-24

Decision Date: 1984-04-13

Contact:

Address:

City: ABBOTT PARK

State: IL

Product Code: DIC

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Toxicology

Advisory Committee Code under which the product was classified: CH

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840567 For ACTIVE LIFE ONE-PIECE STOMA CAP From CONVATEC, A DIVISION OF E.R. SQUIBB & SONS

Date Received: 1984-02-08

Decision Date: 1984-05-02

Contact:

Address:

City: McHenry

State: IL

Product Code: EXB

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840506 For HAEMOPHILUS INFLUENZAE TYPE B From SCIENTIFIC DEVICE LABORATORY, INC.

Date Received: 1984-02-06

Decision Date: 1984-04-04

Contact:

Address:

City: McHenry

State: IL

Product Code: LSC

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Microbiology

Advisory Committee Code under which the product was classified: MI

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840437 For HEMASITE ACCESSORIES MODIFICATION From RENAL SYSTEMS, INC.

Date Received: 1984-02-01

Decision Date: 1984-02-21

Contact:

Address:

City: McHenry

State: IL

Product Code: KNZ

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Gastroenterology, Urology

Advisory Committee Code under which the product was classified: GU

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K840188 For MICROMEDIC LH & FSH RIA KIT From MICROMEDIC SYSTEMS

Date Received: 1984-01-18

Decision Date: 1984-03-23

Contact:

Address:

City: McHenry

State: IL

Product Code: CEP

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Chemistry

Advisory Committee Code under which the product was classified: CH

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K810900 For CASTLE PROCEDURE AND RITTER EXAM. TABLES From SYBRON CORP.

Date Received: 1981-04-03

Decision Date: 1981-04-21

Contact:

Address:

City: McHenry

State: IL

Product Code: LGX

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: General, Plastic Surgery

Advisory Committee Code under which the product was classified: PM

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number K810870 For GEMENI CK-MB ISOENZYME ABNORMAL SERUM From GEMINI, INC.

Date Received: 1981-03-31

Decision Date: 1981-04-14

Contact:

Address:

City: McHenry

State: IL

Product Code: JJT

Decision Code: SESE

Decision Description: Substantially Equivalent

Statement of Summary:

Advisory Committee: Clinical Chemistry

Advisory Committee Code under which the product was classified: CH

Contains Summary or Statement:

Third Party Flag: No

Expedited Review:

510(k) Number/Type	Applicant	Device	Advisory Committe	Date Received	Decision Date	More Info
K841222	ANAEROBE SYSTEMS	BACTEROIDES BILE ESCULIN GAR	Microbiology	1984-03-22	1984-04-04
K841020	HELENA LABORATORIES	FIBRINOGEN ASSAY KIT	Hematology	1984-03-12	1984-05-02
K840987	CONCORD LABORATORIES, INC.	VAPORIZED HEPARIN	Anesthesiology	1984-03-07	1984-04-05
K840826	ABBOTT LABORATORIES	TDX ETHANOL	Clinical Toxicology	1984-02-24	1984-04-13
K840567	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS	ACTIVE LIFE ONE-PIECE STOMA CAP	Gastroenterology, Urology	1984-02-08	1984-05-02
K840506	SCIENTIFIC DEVICE LABORATORY, INC.	HAEMOPHILUS INFLUENZAE TYPE B	Microbiology	1984-02-06	1984-04-04
K840437	RENAL SYSTEMS, INC.	HEMASITE ACCESSORIES MODIFICATION	Gastroenterology, Urology	1984-02-01	1984-02-21
K840188	MICROMEDIC SYSTEMS	MICROMEDIC LH & FSH RIA KIT	Clinical Chemistry	1984-01-18	1984-03-23
K810900	SYBRON CORP.	CASTLE PROCEDURE AND RITTER EXAM. TABLES	General, Plastic Surgery	1981-04-03	1981-04-21
K810870	GEMINI, INC.	GEMENI CK-MB ISOENZYME ABNORMAL SERUM	Clinical Chemistry	1981-03-31	1981-04-14

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