K900621 is an FDA 510(k) clearance for the FIAGEN(TM) HLH.S. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on March 1, 1990, 21 days after receiving the submission on February 8, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K900621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1990 |
| Decision Date | March 01, 1990 |
| Days to Decision | 21 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 |