510(k) K051161

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) by Quest Diagnostics, Inc. — Product Code DKZ

K051161 is an FDA 510(k) premarket notification submitted by Quest Diagnostics, Inc. for the device "QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)". The FDA issued a decision of Substantially Equivalent on November 22, 2005. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Quest Diagnostics, Inc. has at least 6 other 510(k) clearances on record.