510(k) K230868 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Apr 13, 2023 |
| Received | Mar 29, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230868
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.