ClearanceBrief
510(k) K181683 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

BD MAX CT/GC/TV 20-Day QC Panel

ApplicantMicrobiologics, Inc., St. Cloud MN, US
DecisionSubstantially Equivalent, Aug 28, 2018
ReceivedJun 26, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181683

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.