K030012 is an FDA 510(k) clearance for the CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372. This device is classified as a Fluorometric Method, Cpk Or Isoenzymes (Class II - Special Controls, product code JHX).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 17, 2003, 15 days after receiving the submission on January 2, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K030012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2003 |
| Decision Date | January 17, 2003 |
| Days to Decision | 15 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 |