K851521 is an FDA 510(k) clearance for the LD-1(IMMUNO) SEPARATION SET. This device is classified as a Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CEX).
Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 10, 1985, 25 days after receiving the submission on April 15, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K851521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1985 |
| Decision Date | May 10, 1985 |
| Days to Decision | 25 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 |