510(k) K002777

VACUETTE WITH PPACK by Greiner Vacuette North America, Inc. — Product Code JKA

K002777 is an FDA 510(k) premarket notification submitted by Greiner Vacuette North America, Inc. for the device "VACUETTE WITH PPACK". The FDA issued a decision of Substantially Equivalent on October 5, 2000. 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 Vacuette North America, Inc. has at least 4 other 510(k) clearances on record.