510(k) K933939

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT by Organon Teknika Corp. — Product Code GIM

K933939 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.