510(k) K202196 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
BioFire RP2.1/RP2.1plus Control Panel M441
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Jun 24, 2021 |
| Received | Aug 5, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202196
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.