K950510 is an FDA 510(k) clearance for the OCTEIA IGF-1 KIT. This device is classified as a Radioimmunoassay, Human Growth Hormone (Class I - General Controls, product code CFL).
Submitted by Immunodiagnostic Systems , Ltd. (Tyne And Wear, GB). The FDA issued a Cleared decision on April 5, 1995, 58 days after receiving the submission on February 6, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1370.
| 510(k) Number | K950510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1995 |
| Decision Date | April 05, 1995 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CFL — Radioimmunoassay, Human Growth Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1370 |