K182012 is an FDA 510(k) clearance for the ADVIA Centaur Calcitonin (CALCT) assay. This device is classified as a Radioimmunoassay, Calcitonin (Class II - Special Controls, product code JKR).
Submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on December 21, 2018, 147 days after receiving the submission on July 27, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1140.
| 510(k) Number | K182012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JKR - Radioimmunoassay, Calcitonin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1140 |