K132515 is an FDA 510(k) clearance for the LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 8, 2013, 88 days after receiving the submission on August 12, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K132515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2013 |
| Decision Date | November 08, 2013 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEW — Radioimmunoassay, Parathyroid Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1545 |