510(k) K023971

VACUETTE TRACE ELEMENTS TUBES by Greiner Bio-One Vacuette North America — Product Code JKA

K023971 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Vacuette North America for the device "VACUETTE TRACE ELEMENTS TUBES". The FDA issued a decision of Substantially Equivalent on January 27, 2003. 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.