K080481 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS. 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 February 20, 2009, 364 days after receiving the submission on February 22, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K080481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2008 |
| Decision Date | February 20, 2009 |
| Days to Decision | 364 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 |