K981338 is an FDA 510(k) clearance for the LD-1. This device is classified as a Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code JGF).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 18, 1998, 35 days after receiving the submission on April 13, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K981338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1998 |
| Decision Date | May 18, 1998 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |