K821983 is an FDA 510(k) clearance for the TITAN GEL LDH ISOENZYME KIT. This device is classified as a Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CEX).
Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on December 22, 1982, 169 days after receiving the submission on July 6, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K821983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1982 |
| Decision Date | December 22, 1982 |
| Days to Decision | 169 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 |