510(k) K262573 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Oct 21, 2026 |
| Received | Jul 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262573
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.