K890996 is an FDA 510(k) clearance for the LD1 ISOENZYME REAGENT KIT. This device is classified as a Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code JGF).
Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on May 5, 1989, 67 days after receiving the submission on February 27, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K890996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1989 |
| Decision Date | May 05, 1989 |
| Days to Decision | 67 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 |