510(k) K190223 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cepheid Xpert CT/NG Control Panel
| Applicant | Microbiologics, Inc., St. Cloud MN, US |
| Decision | Substantially Equivalent, May 8, 2019 |
| Received | Feb 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190223
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.