510(k) DEN150009 ยท PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
B.R.A.H.M.S PCT sensitive KRYPTOR
| Applicant | Brahms GmbH, Henningsdorf, DE |
| Decision | Unknown, Feb 20, 2016 |
| Received | Mar 4, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150009
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.