510(k) K984359 ยท MMI Immunoassay Method, Troponin Subunit
AIA-PACK TROPONIN I ASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 23, 1998 |
| Received | Dec 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984359
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.