K926394 is an FDA 510(k) clearance for the VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 26, 1993, 156 days after receiving the submission on December 21, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K926394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1992 |
| Decision Date | May 26, 1993 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |