510(k) K981012 ยท DDR Myoglobin, Antigen, Antiserum, Control
AIA-PACK MYOGLOBIN ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, May 28, 1998 |
| Received | Mar 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Myoglobin; Part Number: 025297
Assay, Cardiac Marker Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.