K945367 is an FDA 510(k) clearance for the CIBA CORNING ACS CORTISOL IMMUNOASSAY. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on May 5, 1995, 221 days after receiving the submission on September 26, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K945367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1994 |
| Decision Date | May 05, 1995 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |