K894279 is an FDA 510(k) clearance for the LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 15, 1989, 53 days after receiving the submission on June 23, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K894279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1989 |
| Decision Date | August 15, 1989 |
| Days to Decision | 53 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 |