510(k) K072189 ยท NBC Test, Natriuretic Peptide
PATHFAST NTPROBNP AND D-DIMER TESTS
| Applicant | Mitsubishi Kagaku Iatron, Seattle WA, US |
| Decision | Substantially Equivalent, Feb 5, 2008 |
| Received | Aug 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072189
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2018 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc PATHFAST NTproBNP
Catalog Number: PF1061-KUS
PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pr Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.