510(k) K160911 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
VIDAS B.R.A.H.M.S. PCT (PCT)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 28, 2016 |
| Received | Apr 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160911
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.