510(k) K182472 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cepheid Xpert GBS LB Control Panel
| Applicant | Microbiologics, Inc., St. Cloud MN, US |
| Decision | Substantially Equivalent, Nov 8, 2018 |
| Received | Sep 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182472
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.