Panels › Clinical Chemistry › Product code CGS · Class 2
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (123 all time)
1recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in CGS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2020 | K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set Medtest DX | CGS |
| Apr 17, 2019 | K182702 | SEKURE Creatine Kinase Assay Sekisui Diagnostics P.E.I., Inc., CA | CGS |
| Sep 7, 2016 | K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator Siemens Healthcare Diagnostics, Inc. | CGS |
| Nov 21, 2013 | K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR Randox Laboratories, Ltd., GB | CGS |
| Nov 9, 2011 | K112416 | CPK REAGENT Vital Diagnostics (Manufacturing) Ptyltd, AU | CGS |
| Feb 27, 2009 | K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics | CGS |
| Aug 29, 2008 | K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 Siemens Healthcare Diagnostics | CGS |
| Apr 18, 2008 | K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 Teco Diagnostics | CGS |
| Jun 12, 2007 | K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, FR | CGS |
| Jan 31, 2006 | K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS Arkray, Inc. | CGS |
| Dec 23, 2004 | K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 Olympus America, Inc. | CGS |
| Jul 3, 2002 | K021332 | 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, AR | CGS |
| Jan 18, 2002 | K013912 | CREATINE KINASE (CK-NAC) Jas Diagnostics, Inc. | CGS |
| Oct 3, 2001 | K012474 | ATAC PAK CPK REAGENT KIT Elan Holdings, Inc. | CGS |
| Jan 20, 2000 | K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 Olympus Diagnostica GmbH | CGS |
| Dec 29, 1999 | K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT Morax | CGS |
| Feb 16, 1999 | K983070 | CK Abbott Laboratories | CGS |
| May 1, 1998 | K981218 | CREATINE KINASE (CK) Abbott Laboratories | CGS |
| Mar 26, 1998 | K980900 | N-ASSAY CPK-L Crestat Diagnostics, Inc. | CGS |
| Mar 11, 1998 | K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 Diagnostic Chemicals , Ltd., CA | CGS |
| Feb 13, 1998 | K974833 | CK-NAC REAGENT Intersect Systems, Inc. | CGS |
| Jul 17, 1997 | K972155 | CREATINE KINASE (CK) Stanbio Laboratory | CGS |
| Jul 14, 1997 | K971566 | CREATINE KINASE-MB REAGENT SET Horizon Diagnostics, Inc. | CGS |
| May 29, 1997 | K971396 | CK REAGENT Carolina Liquid Chemistries Corp. | CGS |
| Aug 15, 1996 | K962247 | HICHEM CK/NAC REAGENT KIT Elan Pharma, Inc. | CGS |
| Dec 26, 1995 | K951223 | CK-MB (NAC-ACT) Randox Laboratories, Ltd., IE | CGS |
| Aug 11, 1995 | K952745 | CREATINE KINASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CGS |
| Aug 4, 1995 | K952646 | IL TEST CK-MB Instrumentation Laboratory CO | CGS |
| Mar 3, 1995 | K950177 | CK QVET Prisma Systems | CGS |
| Aug 24, 1994 | K942773 | CK-MB ASSAY, CATALOGUE NUMBER 317-10 Diagnostic Chemicals , Ltd., CA | CGS |
| Jan 11, 1994 | K935463 | CREATINE KINASE-MB (CK-MB) REAGENT SET Pointe Scientific, Inc., | CGS |
| Sep 8, 1993 | K933675 | OPUS TOTAL CK Pb Diagnostic Systems, Inc. | CGS |
| Jul 27, 1993 | K931889 | CREATINE KINASE TEST Em Diagnostic Systems, Inc. | CGS |
| Jun 15, 1993 | K931326 | KING DIAGNOSTICS CK REAGENT King Diagnostics, Inc. | CGS |
| May 11, 1993 | K930932 | SYNERMED CREATINE KINASE REAGENT KIT Synermed, Inc., CA | CGS |
| Mar 29, 1993 | K930660 | CREATINE KINASE (CK) REAGENT SET Pointe Scientific, Inc., | CGS |
| Jan 4, 1993 | K924832 | OLYMPUS CREATINE KINASE REAGENT Olympus Corp. | CGS |
| Dec 28, 1992 | K925801 | REP E-Z CK-30 ISOENZYME KIT Helena Laboratories | CGS |
| Oct 15, 1992 | K923511 | CK-NAC ACTIVATED KIT Randox Laboratories, Ltd., IR | CGS |
| Oct 13, 1992 | K924704 | CREATINE KINASE (CK) TEST ITEM #65411 Em Diagnostic Systems, Inc. | CGS |
| Jul 13, 1992 | K922459 | OLYMPUS CREATINE KINASE REAGENT Olympus Corp. | CGS |
| Jan 27, 1992 | K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET Tech Intl. Co. | CGS |
| Dec 13, 1991 | K914361 | CREATINE KINASE MB TEST ITEM NUMBER 5A46 Em Diagnostic Systems, Inc. | CGS |
| Sep 25, 1991 | K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT Reagents Applications, Inc. | CGS |
| Dec 20, 1990 | K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV Reagents Applications, Inc. | CGS |
| Dec 11, 1990 | K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 Amresco, Inc. | CGS |
| Oct 4, 1990 | K903775 | CREATINE PHOSPHOKINASE Amresco, Inc. | CGS |
| Sep 27, 1990 | K904102 | REFLOTRON CREATINE KINASE TEST TABS Boehringer Mannheim Corp. | CGS |
| Aug 17, 1990 | K903333 | CREATINE KINASE TEST (CK) ITEM NUMBER 65411 Em Diagnostic Systems, Inc. | CGS |
| Jul 10, 1990 | K902483 | CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 Em Diagnostic Systems, Inc. | CGS |
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