510(k) K993491

QUICKPAC II ONE STEP OPIATES TEST by Syntron Bioresearch, Inc. — Product Code DJG

K993491 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUICKPAC II ONE STEP OPIATES TEST". The FDA issued a decision of Substantially Equivalent on October 29, 1999. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.