510(k) K190463 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cepheid Xpert C. difficile/Epi Control Panel
| Applicant | Microbiologics, Inc., St. Cloud MN, US |
| Decision | Substantially Equivalent, Apr 19, 2019 |
| Received | Feb 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2019 | Microbiologics Inc Cepheid Xpert C. difficile/Epi Control Panel Open, Classified |
PMN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.