Differential Rate Kinetic Method, Cpk Or Isoenzymes

FDA product code JHS · 38 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: 1978-05-03 – 2016-05-25

JHS 2016-05-25

Creatine Kinase

Applicant Roche Diagnostics Operations (Rdo)

K number K160570

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JHS 2011-08-19

CKMB UDR ASSAY

Applicant SENTINEL CH. SpA

K number K102706

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JHS 2008-09-18

S40 CREATINE KINASE (CK)

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K082226

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JHS 2006-08-21

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

Applicant Dade Behring, Inc.

K number K062128

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JHS 1999-04-19

CARESIDE CK

Applicant Careside, Inc.

K number K990439

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JHS 1999-04-19

CARESIDE CKMB

Applicant Careside, Inc.

K number K990434

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JHS 1998-06-10

IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)

Applicant Diagnostic Products Corp.

K number K981495

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JHS 1996-06-21

ACS CKMB II IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K962126

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JHS 1995-07-17

STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT

Applicant Dade Intl., Inc.

K number K952250

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JHS 1994-11-21

ACCESS CK-MB REAGENTS

Applicant Bio-Rad Laboratories, Inc.

K number K945083

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JHS 1994-08-02

KINASE ISOENZYME

Applicant Dupont Medical Products

K number K943024

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JHS 1994-07-06

CREATINE KINASE METHOD

Applicant Dupont Medical Products

K number K941584

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JHS 1990-08-09

ROCHE ISOMUNE- CK

Applicant Roche Diagnostic Systems, Inc.

K number K903025

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JHS 1990-03-23

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Healthcare Corp

K number K900806

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JHS 1988-09-30

CHECK-MM

Applicant Intl. Immunoassay Laboratories, Inc.

K number K883223

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JHS 1987-06-17

UNI-FAST CREATINE KINASE TEST (CK)

Applicant Sclavo, Inc.

K number K872029

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JHS 1986-06-27

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)

Applicant Eastman Kodak Company

K number K861387

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JHS 1986-03-05

CPK (UV) REAGENT KIT

Applicant Technostics Intl.

K number K855188

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JHS 1985-12-30

DART CK-MB REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K854708

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JHS 1984-09-07

CARDI-CK EIA TEST KIT CK-MB ISOENZYME

Applicant Intl. Immunoassay Laboratories, Inc.

K number K843007

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JHS 1982-11-22

CK-UV REAGENT

Applicant Biorent Diagnostic, Inc.

K number K823211

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JHS 1982-04-01

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE

Applicant Eastman Kodak Company

K number K820722

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JHS 1981-12-22

CPK(CK) IN VITRO DIAG. REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K813406

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JHS 1981-04-23

WORTHINGTON CK (NAC) REAGENT SET

Applicant Worthington Diagnostic Systems

K number K810997

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JHS 1981-01-09

CARDIOZYME PLUS CK-TOTAL #65046

Applicant Harleco

K number K803169

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JHS 1980-11-12

CK-MB(IMMUNOLOGICAL)

Applicant Biodynamics Corp.

K number K802521

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JHS 1980-08-13

QUICK CEPT

Applicant Laboratory Diagnostics Co., Inc.

K number K801668

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JHS 1980-01-21

WORTHINGTON FLOZYME* CPK (340NM)

Applicant Worthington Diagnostic Systems

K number K800028

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JHS 1979-10-30

ESKACHEM, CK-MB REAGENT

Applicant Smithkline Diagnostics, Inc.

K number K792023

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JHS 1979-06-22

ESKLAB REAGENT TABLETS

Applicant Smithkline Diagnostics, Inc.

K number K790918

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JHS 1979-06-22

SPIN CHEM CK-NAC REAGENT

Applicant Smithkline Diagnostics, Inc.

K number K790917

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JHS 1979-06-22

CK-NUC REAGENT

Applicant Smithkline Diagnostics, Inc.

K number K790916

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JHS 1979-05-01

DATA-ZYME CK CALORIMETRIC/UV PROCEDURE

Applicant Data Medical Associates, Inc.

K number K790343

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JHS 1979-03-12

ACA CREATINE KINASE ISOENZYMES

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

K number K790088

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JHS 1979-02-15

SERUM, CREATININE PHOSPHOKINASE

Applicant Fisher Scientific Co., LLC

K number K790015

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JHS 1978-10-27

L-CYSTEINE HYDROCHLORIDE

Applicant Fisher Scientific Co., LLC

K number K781690

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JHS 1978-10-03

STAT ULTRA VIOLET LIQUID

Applicant Beckman Instruments, Inc.

K number K781432

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JHS 1978-05-03

CREATINE PHOSPHOKINASE (CPK)

Applicant Gamma Enterprises, Inc.

K number K780504

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