K101921 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II - Special Controls, product code CEW).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 22, 2010, 105 days after receiving the submission on July 9, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.
| 510(k) Number | K101921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2010 |
| Decision Date | October 22, 2010 |
| Days to Decision | 105 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 |