Colorimetric Method, Cpk Or Isoenzymes

FDA product code JHY · 37 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1215
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-02 – 2013-10-18

JHY 2013-10-18

ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY

Applicant Roche Diagnostics

K number K132571

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JHY 2007-06-04

OLYMPUS CK-MB REAGENT

Applicant Olympus Life & Material Science Europa GmbH (Irish

K number K070835

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JHY 2002-10-11

SPIFE CK KIT, MODEL 3332, 3333

Applicant Helena Laboratories

K number K022757

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JHY 2002-08-29

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

Applicant Roche Diagnostics Corp.

K number K022654

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JHY 1997-12-17

ELECSYS CK-MB STAT

Applicant Boehringer Mannheim Corp.

K number K974421

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JHY 1997-02-14

MMB METHOD

Applicant Dade Chemistry Systems, Inc.

K number K970343

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JHY 1996-06-18

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO

Applicant Bayer Corp.

K number K961412

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JHY 1995-05-02

AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

Applicant Organon Teknika Corp.

K number K951638

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JHY 1993-06-15

IMX(R) STAT CK-MB

Applicant Abbott Laboratories

K number K931172

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JHY 1992-10-15

OPUS(R) CK-MB

Applicant Pb Diagnostic Systems, Inc.

K number K924429

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JHY 1992-08-20

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K922700

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JHY 1992-06-09

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K921763

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JHY 1991-07-17

AMERLITE CK-MB ASSAY

Applicant Amersham Corp.

K number K912766

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JHY 1990-02-16

COBAS READY CK REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K896240

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JHY 1989-12-01

ISOSCREEN-CK CONFIRMATORY KIT

Applicant Roche Diagnostic Systems, Inc.

K number K895870

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JHY 1989-08-15

TARGET(TM) CK-MB

Applicant V-Tech, Inc.

K number K890295

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JHY 1989-02-23

CREATINE KINASE MB ENZYME IMMUNOASSAY KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K884550

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JHY 1988-12-02

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K884085

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JHY 1988-08-08

IMX CKMB

Applicant Abbott Laboratories

K number K883013

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JHY 1988-06-01

IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225

Applicant Intl. Immunoassay Laboratories, Inc.

K number K881351

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JHY 1988-02-24

KODAK EKTACHEM DT SLIDES (CKMB)

Applicant Eastman Kodak Company

K number K875192

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JHY 1988-02-18

CREATINE KINASE (COLORIMETRIC METHOD)

Applicant Tech-Co, Inc.

K number K880178

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JHY 1987-12-18

IMACK-MB TEST PROCEDURE (MODIFICATION)

Applicant Intl. Immunoassay Laboratories, Inc.

K number K874545

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JHY 1987-06-19

TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

Applicant Hybritech, Inc.

K number K872063

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JHY 1987-05-12

CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS

Applicant Catachem, Inc.

K number K871677

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JHY 1986-04-11

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT

Applicant Amresco, Inc.

K number K860663

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JHY 1985-01-18

BAKER CKMB REAGENT SET

Applicant Hybritech, Inc.

K number K845024

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JHY 1984-04-05

FLOW-PAC CPK REAGENT SET

Applicant American Research Products Co.

K number K832977

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JHY 1983-08-12

TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K832139

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JHY 1983-08-11

WAKO CPK TEST

Applicant Wako Chemicals USA, Inc.

K number K832004

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JHY 1983-04-05

CREATINE KINASE REAGENT SET

Applicant Sterling Biochemical, Inc.

K number K830672

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JHY 1982-04-12

CREATINE KINASE-MB KIT

Applicant Calbiochem-Behring Corp.

K number K820812

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JHY 1980-05-28

REAGENT FOR DETERM. CREATINE PHOSPHOKINA

Applicant Diagnostic Solutions, Inc.

K number K800684

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JHY 1979-09-17

CPK ISOENZYME REAGENT

Applicant Electrophoresis Corp. of America

K number K791655

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JHY 1979-04-04

CPK ISOENZYME SUBSTRATE

Applicant Electrophoresis Corp.

K number K790309

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JHY 1976-12-21

CPK1SOENZYMES DETERMINATION PRO. #715-EP

Applicant Sigma Chemical Co.

K number K761212

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JHY 1976-11-02

LANCER MB/CPK ISOENZYME KIT

Applicant Sherwood Medical Industries

K number K760871

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