K914261 is an FDA 510(k) clearance for the ABBOTT QUICKSTART LD-1,#5A30. 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 October 21, 1991, 28 days after receiving the submission on September 23, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K914261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1991 |
| Decision Date | October 21, 1991 |
| Days to Decision | 28 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 |