510(k) K181002 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Atellica IM BRAHMS Procalcitonin (PCT)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 16, 2018 |
| Received | Apr 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181002
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.