ClearanceBrief
510(k) K053032 ยท DKZ Enzyme Immunoassay, Amphetamine

ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000

ApplicantAcro Biotech, LLC, Rancho Cucamonga CA, US
DecisionSubstantially Equivalent, Feb 9, 2006
ReceivedOct 27, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K053032

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.