K132828 is an FDA 510(k) clearance for the ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3. This device is classified as a Radioimmunoassay, Calcitonin (Class II - Special Controls, product code JKR).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 4, 2013, 86 days after receiving the submission on September 9, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1140.
| 510(k) Number | K132828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2013 |
| Decision Date | December 04, 2013 |
| Days to Decision | 86 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 |