K221197 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Intact PTH II Reagent Pack. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on September 5, 2023, 498 days after receiving the submission on April 25, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K221197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2022 |
| Decision Date | September 05, 2023 |
| Days to Decision | 498 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 |