510(k) K980349

QUICKPAC II ONE STEP BARBITURATE TEST by Syntron Bioresearch, Inc. — Product Code DIS

K980349 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUICKPAC II ONE STEP BARBITURATE TEST". The FDA issued a decision of Substantially Equivalent on March 3, 1998. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.