510(k) K181412 ยท QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
VITEK MS
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 21, 2018 |
| Received | May 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181412
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.