K212648 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products CK-MB Reagent Pack. This device is classified as a Fluorometric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHX).
Submitted by Ortho-Clinical Diagnostics (Pencoed, GB). The FDA issued a Cleared decision on January 28, 2022, 158 days after receiving the submission on August 23, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K212648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2021 |
| Decision Date | January 28, 2022 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHX — Fluorometric Method, Cpk Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |