ClearanceBrief
510(k) K122904 ยท DKZ Enzyme Immunoassay, Amphetamine

WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

ApplicantGuangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US
DecisionSubstantially Equivalent, Nov 15, 2012
ReceivedSep 21, 2012
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K122904

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.