ClearanceBrief
510(k) K853548 ยท LCM Enzyme Immunoassay, Phencyclidine

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS

ApplicantAmerican Dade, Santa Ana CA, US
DecisionSubstantially Equivalent, Sep 18, 1985
ReceivedAug 26, 1985
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K853548

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.