K925188 is an FDA 510(k) clearance for the ABBOTT QUICKSTART LD-1, MODIFICATION. This device is classified as a Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code JGF).
Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 5, 1993, 120 days after receiving the submission on October 8, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K925188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |