CGS — Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Class II
FDA Device Classification
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 |