510(k) K913298 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
AIA-PACK CK-MB
| Applicant | Tosoh Corp., Washington, D.C. DC, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Jul 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK CK-MB; Part Number: 025269
Assay, Cardiac Marker Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.