K993068 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 (Rochester, US). The FDA issued a Cleared decision on October 4, 1999, 21 days after receiving the submission on September 13, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K993068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1999 |
| Decision Date | October 04, 1999 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |