510(k) K081360 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
PATHFAST CK-MB-II, PATHFAST MYO-II
| Applicant | Mitsubishi Kagaku Iatron, Seattle WA, US |
| Decision | Substantially Equivalent, Aug 17, 2009 |
| Received | May 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2018 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc PATHFAST Myoglobin II reagent cartridge
Catalog Number: PF1111-K
PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measureme Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.