CGS · Class II · 21 CFR 862.1215

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
1–24 of 123
Cleared Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296
Medtest DX
Chemistry · 455d
Cleared Apr 17, 2019
SEKURE Creatine Kinase Assay
K182702
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 202d
Cleared Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
K160724
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977
Randox Laboratories, Ltd.
Chemistry · 330d
Cleared Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
K083465
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
K081731
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Apr 18, 2008
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548
Teco Diagnostics
Chemistry · 221d
Cleared Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202
Olympus America, Inc.
Chemistry · 35d
Cleared Feb 16, 1999
CK
K983070
Abbott Laboratories
Chemistry · 167d
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218
Abbott Laboratories
Chemistry · 28d
Cleared Mar 11, 1998
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
K973999
Diagnostic Chemicals , Ltd.
Chemistry · 141d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155
Stanbio Laboratory
Chemistry · 42d
Cleared Dec 26, 1995
CK-MB (NAC-ACT)
K951223
Randox Laboratories, Ltd.
Chemistry · 281d
Cleared Aug 11, 1995
CREATINE KINASE REAGENT SYSTEM
K952745
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 04, 1995
IL TEST CK-MB
K952646
Instrumentation Laboratory CO
Chemistry · 56d
Cleared Aug 24, 1994
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773
Diagnostic Chemicals , Ltd.
Chemistry · 72d
Cleared Jan 11, 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Sep 08, 1993
OPUS TOTAL CK
K933675
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jul 27, 1993
CREATINE KINASE TEST
K931889
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jun 15, 1993
KING DIAGNOSTICS CK REAGENT
K931326
King Diagnostics, Inc.
Chemistry · 91d
Cleared May 11, 1993
SYNERMED CREATINE KINASE REAGENT KIT
K930932
Synermed, Inc.
Chemistry · 77d
Cleared Mar 29, 1993
CREATINE KINASE (CK) REAGENT SET
K930660
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Jan 04, 1993
OLYMPUS CREATINE KINASE REAGENT
K924832
Olympus Corp.
Chemistry · 101d
Cleared Dec 28, 1992
REP E-Z CK-30 ISOENZYME KIT
K925801
Helena Laboratories
Chemistry · 42d

About Product Code CGS - Regulatory Context