K060480 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS. This device is classified as a Radioimmunoassay, Cortisol (Class II - Special Controls, product code CGR).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on July 3, 2006, 130 days after receiving the submission on February 23, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1205.
| 510(k) Number | K060480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2006 |
| Decision Date | July 03, 2006 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGR — Radioimmunoassay, Cortisol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1205 |