510(k) K011699

VACUETTE EVACUATED BLOOD COLLECTION TUBES by Greiner Bio-One Vacuette North America — Product Code JKA

K011699 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Vacuette North America for the device "VACUETTE EVACUATED BLOOD COLLECTION TUBES". The FDA issued a decision of Substantially Equivalent on June 28, 2001. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Greiner Bio-One Vacuette North America has at least 4 other 510(k) clearances on record.