FDA 510(k) Applications for Medical Device Product Code "CGS"
(Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983070 | ABBOTT LABORATORIES | CK | 02/16/1999 |
| K981218 | ABBOTT LABORATORIES | CREATINE KINASE (CK) | 05/01/1998 |
| K051648 | ARKRAY, INC. | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | 01/31/2006 |
| K971396 | CAROLINA LIQUID CHEMISTRIES CORP. | CK REAGENT | 05/29/1997 |
| K980900 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY CPK-L | 03/26/1998 |
| K973999 | DIAGNOSTIC CHEMICALS LTD. | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | 03/11/1998 |
| K012474 | ELAN HOLDINGS, INC. | ATAC PAK CPK REAGENT KIT | 10/03/2001 |
| K962247 | ELAN PHARMA, INC. | HICHEM CK/NAC REAGENT KIT | 08/15/1996 |
| K062737 | HORIBA ABX | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | 06/12/2007 |
| K971566 | HORIZON DIAGNOSTICS, INC. | CREATINE KINASE-MB REAGENT SET | 07/14/1997 |
| K974833 | INTERSECT SYSTEMS, INC. | CK-NAC REAGENT | 02/13/1998 |
| K013912 | JAS Diagnostics, Inc. | CREATINE KINASE (CK-NAC) | 01/18/2002 |
| K191296 | MedTest Dx | Pointe Scientific Creatinine Kinase (CK) Reagent Set | 08/11/2020 |
| K992148 | MORAX | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | 12/29/1999 |
| K043202 | OLYMPUS AMERICA, INC. | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | 12/23/2004 |
| K994189 | OLYMPUS DIAGNOSTICA GMBH | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | 01/20/2000 |
| K123977 | RANDOX LABORATORIES, LTD. | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | 11/21/2013 |
| K182702 | SEKISUI DIAGNOSTICS P.E.I. INC. | SEKURE Creatine Kinase Assay | 04/17/2019 |
| K081731 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | 08/29/2008 |
| K083465 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE | 02/27/2009 |
| K160724 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | 09/07/2016 |
| K972155 | STANBIO LABORATORY | CREATINE KINASE (CK) | 07/17/1997 |
| K072548 | TECO DIAGNOSTICS | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | 04/18/2008 |
| K112416 | VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD | CPK REAGENT | 11/09/2011 |
| K021332 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA | 07/03/2002 |
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