K021229 is an FDA 510(k) clearance for the MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 28, 2002, 71 days after receiving the submission on April 18, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K021229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2002 |
| Decision Date | June 28, 2002 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |