510(k) K043051

QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 by Phamatech, Inc. — Product Code DJG

K043051 is an FDA 510(k) premarket notification submitted by Phamatech, Inc. for the device "QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121". The FDA issued a decision of Substantially Equivalent on February 7, 2005. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Phamatech, Inc. has at least 10 other 510(k) clearances on record.