K060585 is an FDA 510(k) clearance for the ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH. This device is classified as a Radioimmunoassay, Acth (Class II - Special Controls, product code CKG).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 3, 2006, 57 days after receiving the submission on March 7, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1025.
| 510(k) Number | K060585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2006 |
| Decision Date | May 03, 2006 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CKG — Radioimmunoassay, Acth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1025 |