K882340 is an FDA 510(k) clearance for the LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on August 8, 1988, 62 days after receiving the submission on June 7, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K882340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1988 |
| Decision Date | August 08, 1988 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |