Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA product code CGS · 123 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: 1977-01-05 – 2020-08-11

CGS 2020-08-11

Pointe Scientific Creatinine Kinase (CK) Reagent Set

Applicant Medtest DX

K number K191296

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CGS 2019-04-17

SEKURE Creatine Kinase Assay

Applicant Sekisui Diagnostics P.E.I., Inc.

K number K182702

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CGS 2016-09-07

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

Applicant Siemens Healthcare Diagnostics, Inc.

K number K160724

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CGS 2013-11-21

RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

Applicant Randox Laboratories, Ltd.

K number K123977

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CGS 2011-11-09

CPK REAGENT

Applicant Vital Diagnostics (Manufacturing) Ptyltd

K number K112416

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CGS 2009-02-27

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

Applicant Siemens Healthcare Diagnostics

K number K083465

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CGS 2008-08-29

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

Applicant Siemens Healthcare Diagnostics

K number K081731

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CGS 2008-04-18

CREATINE KINASE LIQUID REAGENT, MODEL C519-440

Applicant Teco Diagnostics

K number K072548

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CGS 2007-06-12

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

Applicant Horiba Abx

K number K062737

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CGS 2006-01-31

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

Applicant Arkray, Inc.

K number K051648

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CGS 2004-12-23

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

Applicant Olympus America, Inc.

K number K043202

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CGS 2002-07-03

WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA

Applicant Wiener Laboratories Saic

K number K021332

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CGS 2002-01-18

CREATINE KINASE (CK-NAC)

Applicant Jas Diagnostics, Inc.

K number K013912

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CGS 2001-10-03

ATAC PAK CPK REAGENT KIT

Applicant Elan Holdings, Inc.

K number K012474

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CGS 2000-01-20

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279

Applicant Olympus Diagnostica GmbH

K number K994189

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CGS 1999-12-29

HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT

Applicant Morax

K number K992148

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CGS 1999-02-16

CK

Applicant Abbott Laboratories

K number K983070

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CGS 1998-05-01

CREATINE KINASE (CK)

Applicant Abbott Laboratories

K number K981218

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CGS 1998-03-26

N-ASSAY CPK-L

Applicant Crestat Diagnostics, Inc.

K number K980900

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CGS 1998-03-11

CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30

Applicant Diagnostic Chemicals , Ltd.

K number K973999

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CGS 1998-02-13

CK-NAC REAGENT

Applicant Intersect Systems, Inc.

K number K974833

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CGS 1997-07-17

CREATINE KINASE (CK)

Applicant Stanbio Laboratory

K number K972155

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CGS 1997-07-14

CREATINE KINASE-MB REAGENT SET

Applicant Horizon Diagnostics, Inc.

K number K971566

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CGS 1997-05-29

CK REAGENT

Applicant Carolina Liquid Chemistries Corp.

K number K971396

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CGS 1996-08-15

HICHEM CK/NAC REAGENT KIT

Applicant Elan Pharma, Inc.

K number K962247

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CGS 1995-12-26

CK-MB (NAC-ACT)

Applicant Randox Laboratories, Ltd.

K number K951223

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CGS 1995-08-11

CREATINE KINASE REAGENT SYSTEM

Applicant Medical Diagnostic Technologies, Inc.

K number K952745

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CGS 1995-08-04

IL TEST CK-MB

Applicant Instrumentation Laboratory CO

K number K952646

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CGS 1995-03-03

CK QVET

Applicant Prisma Systems

K number K950177

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CGS 1994-08-24

CK-MB ASSAY, CATALOGUE NUMBER 317-10

Applicant Diagnostic Chemicals , Ltd.

K number K942773

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CGS 1994-01-11

CREATINE KINASE-MB (CK-MB) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K935463

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CGS 1993-09-08

OPUS TOTAL CK

Applicant Pb Diagnostic Systems, Inc.

K number K933675

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CGS 1993-07-27

CREATINE KINASE TEST

Applicant Em Diagnostic Systems, Inc.

K number K931889

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CGS 1993-06-15

KING DIAGNOSTICS CK REAGENT

Applicant King Diagnostics, Inc.

K number K931326

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CGS 1993-05-11

SYNERMED CREATINE KINASE REAGENT KIT

Applicant Synermed, Inc.

K number K930932

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CGS 1993-03-29

CREATINE KINASE (CK) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K930660

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CGS 1993-01-04

OLYMPUS CREATINE KINASE REAGENT

Applicant Olympus Corp.

K number K924832

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CGS 1992-12-28

REP E-Z CK-30 ISOENZYME KIT

Applicant Helena Laboratories

K number K925801

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CGS 1992-10-15

CK-NAC ACTIVATED KIT

Applicant Randox Laboratories, Ltd.

K number K923511

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CGS 1992-10-13

CREATINE KINASE (CK) TEST ITEM #65411

Applicant Em Diagnostic Systems, Inc.

K number K924704

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CGS 1992-07-13

OLYMPUS CREATINE KINASE REAGENT

Applicant Olympus Corp.

K number K922459

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CGS 1992-01-27

CREATINE KINASE-MB (CK-MB) REAGENT SET

Applicant Tech Intl. Co.

K number K915709

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CGS 1991-12-13

CREATINE KINASE MB TEST ITEM NUMBER 5A46

Applicant Em Diagnostic Systems, Inc.

K number K914361

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CGS 1991-09-25

RAICHEM(TM) CREATINE KINASE-MB REAGENT

Applicant Reagents Applications, Inc.

K number K913398

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CGS 1990-12-20

RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV

Applicant Reagents Applications, Inc.

K number K905084

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CGS 1990-12-11

AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

Applicant Amresco, Inc.

K number K904004

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CGS 1990-10-04

CREATINE PHOSPHOKINASE

Applicant Amresco, Inc.

K number K903775

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CGS 1990-09-27

REFLOTRON CREATINE KINASE TEST TABS

Applicant Boehringer Mannheim Corp.

K number K904102

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CGS 1990-08-17

CREATINE KINASE TEST (CK) ITEM NUMBER 65411

Applicant Em Diagnostic Systems, Inc.

K number K903333

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CGS 1990-07-10

CREATINE KINASE-MB TEST (MB-DS) ITEM #67655

Applicant Em Diagnostic Systems, Inc.

K number K902483

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CGS 1990-05-23

COULTER CK (CREATINE KINASE) REAGENT

Applicant Coulter Corp.

K number K901267

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CGS 1989-11-08

CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS

Applicant Catachem, Inc.

K number K894715

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CGS 1989-08-31

EMDS CREATINE KINASE ITEM NIMBER 65411

Applicant Diagnostic Systems

K number K893691

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CGS 1989-07-20

BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME

Applicant Beckman Instruments, Inc.

K number K893269

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CGS 1989-07-20

REP(TM) CK-2 STAT KIT, CAT. NO. 3074

Applicant Helena Laboratories

K number K893007

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CGS 1989-05-22

ROCHE(R) CARDIOSCREEN-CK

Applicant Roche Diagnostic Systems, Inc.

K number K891462

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CGS 1989-05-09

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

Applicant Trace Scientific , Ltd.

K number K891470

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CGS 1989-03-16

IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

Applicant Intl. Immunoassay Laboratories, Inc.

K number K890609

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CGS 1989-02-27

ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC

Applicant Abbott Laboratories

K number K890540

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CGS 1989-02-10

CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673

Applicant Em Diagnostic Systems, Inc.

K number K884547

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CGS 1989-02-02

CREATINE KINASE TEST (CK) ITEM NUMBER: 65661

Applicant Em Diagnostic Systems, Inc.

K number K884546

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CGS 1988-10-13

VISION CREATINE KINASE

Applicant Abbott Laboratories

K number K883946

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CGS 1988-09-13

DURAZYME(R) CPK

Applicant American Monitor Corp.

K number K883504

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CGS 1987-11-05

TITAN GEL REP CPK-12 HV

Applicant Helena Laboratories

K number K874146

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CGS 1987-11-05

WAKO(TM) AUTOKIT CK-NAC

Applicant Wako Chemicals USA, Inc.

K number K873201

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CGS 1987-11-03

TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.

Applicant Helena Laboratories

K number K874140

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CGS 1987-11-03

TITAN GEL REP CPK-30 HV

Applicant Helena Laboratories

K number K874139

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CGS 1987-09-16

UNIFAST CK-MB

Applicant Sclavo, Inc.

K number K873134

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CGS 1987-03-10

EASY-TEST CREATINE KINASE-MB (CK-MB) #16615

Applicant Em Diagnostic Systems, Inc.

K number K870462

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CGS 1987-03-06

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614

Applicant Em Diagnostic Systems, Inc.

K number K870461

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CGS 1987-02-06

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)

Applicant Trace Scientific , Ltd.

K number K864359

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CGS 1987-01-13

CREATINE PHOSPHOKINASE (CK)

Applicant Tech-Co, Inc.

K number K864744

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CGS 1986-10-03

CREATINE PHOSPHOKINASE(CK) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863587

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CGS 1986-06-05

CREATINE PHROSPHOKINASE (CK) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861665

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CGS 1986-05-29

CK REAGENT CARTRIDGE (PRODUCT NO. 88213)

Applicant Hi Chem, Inc.

K number K861879

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CGS 1986-04-24

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK

Applicant Em Diagnostic Systems, Inc.

K number K861061

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CGS 1986-04-24

CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE

Applicant Trace Scientific , Ltd.

K number K860733

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CGS 1986-04-07

CREATINE KINASE, N-ACETYL-L-CYSTIENE

Applicant Em Diagnostic Systems, Inc.

K number K860669

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CGS 1986-02-11

CPK REAGENT SET (COLORIMETRIC)

Applicant Sterling Diagnostics, Inc.

K number K860096

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CGS 1986-01-22

EMDS TOTAL CK TEST PACK-#67670/95

Applicant Em Diagnostic Systems, Inc.

K number K855056

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CGS 1985-12-04

CK(OPTIMIZED) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K854501

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CGS 1985-10-22

EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE

Applicant Helena Laboratories

K number K852392

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CGS 1985-07-12

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205

Applicant Em Diagnostic Systems, Inc.

K number K852483

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CGS 1985-05-30

CK-NAC REAGENT

Applicant Alpkem Corp.

K number K852000

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CGS 1985-02-07

ISOENZYME TEST CK-MB

Applicant Sclavo, Inc.

K number K850212

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CGS 1984-09-28

TITAN GEL ISO DOT CPK PROCEDURE

Applicant Helena Laboratories

K number K842755

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CGS 1984-09-07

SYSTEMATE CK-TOTAL - 67206

Applicant Em Diagnostic Systems, Inc.

K number K843271

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CGS 1984-07-20

CREATINE KINASE ASSAY KIT NAC

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842508

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CGS 1984-06-25

SIGMA PROCEDURE 47-UV

Applicant Sigma Chemical Co.

K number K842013

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CGS 1984-04-04

CREATINE KINASE MB REAGENT

Applicant American Dade

K number K840783

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CGS 1984-02-27

CK-NAC REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K834502

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CGS 1984-01-18

DURAZYME CPK

Applicant American Monitor Corp.

K number K833781

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CGS 1983-09-12

CREATINE KINASE REAGENT CK LTS

Applicant Electro-Nucleonics Laboratories, Inc.

K number K831965

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CGS 1983-06-22

PARAMAX CREATINE KINASE REAGENT

Applicant American Dade

K number K831537

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CGS 1982-07-14

ULTRAZYME PLUS CK-I

Applicant Harleco Diagnostics

K number K821883

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CGS 1982-06-03

ULTRAZYME PLUS CKI, #64978,65027&65028

Applicant Emd Chemicals, Inc.

K number K821473

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CGS 1982-06-02

CARDIOZYME PLUS CK-MB, #65045

Applicant Emd Chemicals, Inc.

K number K821464

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CGS 1982-06-01

ULTRAZYME PLUS CK-I, #64978,65027&65028

Applicant Emd Chemicals, Inc.

K number K821460

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CGS 1982-05-21

LIQUID-STAT LIQUID ENZYME REAGENT

Applicant Beckman Instruments, Inc.

K number K821240

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CGS 1982-04-16

SERALYZER CK REAGENT STRIPS

Applicant Miles Laboratories, Inc.

K number K820880

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