510(k) K970343 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
MMB METHOD
| Applicant | Dade Chemistry Systems, Inc., Glasgow DE, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Jan 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970343
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.