510(k) K241289 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, May 30, 2024 |
| Received | May 7, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241289
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.