CGS — Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Class II
FDA product code CGS covers "Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGS
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191296 | medtest dx | Pointe Scientific Creatinine Kinase (CK) Reagent Set | August 11, 2020 |
| K182702 | sekisui diagnostics p.e.i | SEKURE Creatine Kinase Assay | April 17, 2019 |
| K160724 | siemens healthcare diagnostics | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrato | September 7, 2016 |
| K123977 | randox laboratories | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | November 21, 2013 |
| K112416 | vital diagnostics (manufacturing) ptyltd | CPK REAGENT | November 9, 2011 |
| K083465 | siemens healthcare diagnostics | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREAT | February 27, 2009 |
| K081731 | siemens healthcare diagnostics | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND | August 29, 2008 |
| K072548 | teco diagnostics | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | April 18, 2008 |
| K062737 | horiba abx | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | June 12, 2007 |
| K051648 | arkray | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | January 31, 2006 |
| K043202 | olympus america | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | December 23, 2004 |
| K021332 | wiener laboratories saic | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV A | July 3, 2002 |
| K013912 | jas diagnostics | CREATINE KINASE (CK-NAC) | January 18, 2002 |
| K012474 | elan holdings | ATAC PAK CPK REAGENT KIT | October 3, 2001 |
| K994189 | olympus diagnostica | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | January 20, 2000 |
| K992148 | morax | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL I | December 29, 1999 |
| K983070 | abbott laboratories | CK | February 16, 1999 |
| K981218 | abbott laboratories | CREATINE KINASE (CK) | May 1, 1998 |
| K980900 | crestat diagnostics | N-ASSAY CPK-L | March 26, 1998 |
| K973999 | diagnostic chemicals | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | March 11, 1998 |