K811024 is an FDA 510(k) clearance for the LUTEINIZING HORMONE DIRECT RIA KIT 125/I. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981, 23 days after receiving the submission on April 15, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K811024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1981 |
| Decision Date | May 08, 1981 |
| Days to Decision | 23 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 |