510(k) K233611 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Mar 26, 2024 |
| Received | Nov 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233611
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.