K882823 is an FDA 510(k) clearance for the FIAGEN HGH FLUOROIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Human Growth Hormone (Class I - General Controls, product code CFL).
Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on August 30, 1988, 53 days after receiving the submission on July 8, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1370.
| 510(k) Number | K882823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1988 |
| Decision Date | August 30, 1988 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFL — Radioimmunoassay, Human Growth Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1370 |