K871240 is an FDA 510(k) clearance for the ABBOTT A-GENT LD-1 ISOZYME REAGENT. This device is classified as a Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code JGF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 13, 1987, 47 days after receiving the submission on March 27, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K871240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1987 |
| Decision Date | May 13, 1987 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |