FDA Product Code CGS: Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Leading manufacturers include Em Diagnostic Systems, Inc., Helena Laboratories and Harleco.
123
Total
123
Cleared
65d
Avg days
1977
Since
FDA 510(k) Cleared Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes Devices (Product Code CGS)
123 devices
Cleared
Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
Medtest DX
Chemistry
455d
Cleared
Apr 17, 2019
SEKURE Creatine Kinase Assay
Sekisui Diagnostics P.E.I., Inc.
Chemistry
202d
Cleared
Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
Siemens Healthcare Diagnostics, Inc.
Chemistry
175d
Cleared
Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
Randox Laboratories, Ltd.
Chemistry
330d
Cleared
Nov 09, 2011
CPK REAGENT
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry
79d
Cleared
Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
Siemens Healthcare Diagnostics
Chemistry
95d
Cleared
Aug 29, 2008
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
Siemens Healthcare Diagnostics
Chemistry
71d
Cleared
Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
Teco Diagnostics
Chemistry
221d
Cleared
Jun 12, 2007
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Horiba Abx
Chemistry
272d
Cleared
Jan 31, 2006
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
Arkray, Inc.
Chemistry
224d
Cleared
Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
Olympus America, Inc.
Chemistry
35d
Cleared
Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
Wiener Laboratories Saic
Chemistry
68d
Cleared
Jan 18, 2002
CREATINE KINASE (CK-NAC)
Jas Diagnostics, Inc.
Chemistry
52d
Cleared
Jan 20, 2000
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
Olympus Diagnostica GmbH
Chemistry
38d
Cleared
Dec 29, 1999
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
Morax
Chemistry
188d
Cleared
Feb 16, 1999
CK
Abbott Laboratories
Chemistry
167d
Cleared
May 01, 1998
CREATINE KINASE (CK)
Abbott Laboratories
Chemistry
28d
Cleared
Mar 26, 1998
N-ASSAY CPK-L
Crestat Diagnostics, Inc.
Chemistry
16d
Cleared
Mar 11, 1998
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
Diagnostic Chemicals , Ltd.
Chemistry
141d
Cleared
Feb 13, 1998
CK-NAC REAGENT
Intersect Systems, Inc.
Chemistry
51d
Cleared
Jul 17, 1997
CREATINE KINASE (CK)
Stanbio Laboratory
Chemistry
42d
Cleared
Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
Horizon Diagnostics, Inc.
Chemistry
76d
Cleared
May 29, 1997
CK REAGENT
Carolina Liquid Chemistries Corp.
Chemistry
44d
Cleared
Aug 15, 1996
HICHEM CK/NAC REAGENT KIT
Elan Pharma, Inc.
Chemistry
65d