510(k) K984433 ยท MYT Biosensor, Immunoassay, Cpk Or Isoenzymes
QUANTECH CK-MB ASSAY
| Applicant | Quantech , Ltd., Northridge CA, US |
| Decision | Substantially Equivalent, Nov 1, 1999 |
| Received | Dec 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984433
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.