510(k) K071146 ยท NTM Antigen, Inflammatory Response Marker, Sepsis
VIDAS B.R.A.H.M.S. PCT ASSAY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 11, 2007 |
| Received | Apr 24, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 Open, Classified |
NTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.