ClearanceBrief
510(k) K945610 ยท DKZ Enzyme Immunoassay, Amphetamine

ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP

ApplicantPrinceton BioMeditech Corp., Princeton NJ, US
DecisionSubstantially Equivalent, Apr 13, 1995
ReceivedNov 15, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K945610

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.