510(k) K073091 ยท NBC Test, Natriuretic Peptide
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 29, 2008 |
| Received | Nov 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2016 | Biomerieux France Chemin De L'Or VIDAS NT-pro-BNP
Product Usage:
VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriureti Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.