510(k) K954997

CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT by Centocor, Inc. — Product Code JOZ

K954997 is an FDA 510(k) premarket notification submitted by Centocor, Inc. for the device "CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Centocor, Inc. has at least 2 other 510(k) clearances on record.