ClearanceBrief
510(k) K944063 ยท LGI Fluorescence Polarization Immunoassay, Carbamazepine

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE

ApplicantSigma Diagnostics, Inc., St. Louis MO, US
DecisionSubstantially Equivalent, Nov 10, 1994
ReceivedAug 19, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K944063

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.