510(k) K050593

ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE by ACON Laboratories, Inc. — Product Code DIS

K050593 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.