ClearanceBrief
510(k) K170509 ยท PUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

ApplicantBio-Rad Laboratories, Benicia CA, US
DecisionSubstantially Equivalent, May 19, 2017
ReceivedFeb 21, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K170509

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.