K083465 is an FDA 510(k) clearance for the DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE. This device is classified as a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II - Special Controls, product code CGS).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 27, 2009, 95 days after receiving the submission on November 24, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K083465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2008 |
| Decision Date | February 27, 2009 |
| Days to Decision | 95 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |