510(k) K221253 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
| Applicant | Maine Molecular Quality Controls, Inc., Saco ME, US |
| Decision | Substantially Equivalent, Feb 3, 2023 |
| Received | May 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221253
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.