510(k) K254167 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
MDx-Chex for BCY
| Applicant | Streck, LLC, La Vista NE, US |
| Decision | Substantially Equivalent, Mar 17, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254167
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.