K081731 is an FDA 510(k) clearance for the DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32. 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 August 29, 2008, 71 days after receiving the submission on June 19, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K081731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2008 |
| Decision Date | August 29, 2008 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| 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 |