510(k) K251526 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
FilmArray GI Control Panel M238
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Aug 14, 2025 |
| Received | May 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251526
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.