K983176 is an FDA 510(k) clearance for the ELECSYS MYOGLOBIN STAT ASSAY. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 24, 1998, 14 days after receiving the submission on September 10, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K983176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1998 |
| Decision Date | September 24, 1998 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |