510(k) K212576 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
MDx-Chex for BCID2
| Applicant | Streck, Inc., La Vista NE, US |
| Decision | Substantially Equivalent, Jan 19, 2022 |
| Received | Aug 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212576
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.