K163658 is an FDA 510(k) clearance for the ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on May 23, 2017, 151 days after receiving the submission on December 23, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K163658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2016 |
| Decision Date | May 23, 2017 |
| Days to Decision | 151 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 |