K800129 is an FDA 510(k) clearance for the CENTRIFICHEM CREATININE. This device is classified as a Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CEX).
Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980, 26 days after receiving the submission on January 18, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K800129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1980 |
| Decision Date | February 13, 1980 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |