K042982 is an FDA 510(k) clearance for the QUANTEX MYOGLOBIN. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 22, 2004, 54 days after receiving the submission on October 29, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K042982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 54 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 |