510(k) K012820 ยท MMI Immunoassay Method, Troponin Subunit
AIA-PACK CTNI 2ND-GEN ASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 14, 2001 |
| Received | Aug 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK cTnI 2nd Gen; Part Number: 025205
Assay, Cardiac Marker Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.