510(k) K191168 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cepheid Xpert SA Nasal Complete Control Panel
| Applicant | Microbiologics, Inc., St. Cloud MN, US |
| Decision | Substantially Equivalent, Jun 25, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191168
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.