ClearanceBrief
510(k) K201403 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

NATtrol BD MAX Vaginal Panel External Controls

ApplicantZeptometrix, Buffalo NY, US
DecisionSubstantially Equivalent, Feb 2, 2022
ReceivedMay 28, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201403

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.