K915850 is an FDA 510(k) clearance for the OPUS MYOGLOBIN TEST SYSTEM. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on March 17, 1992, 82 days after receiving the submission on December 26, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K915850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1991 |
| Decision Date | March 17, 1992 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |