510(k) K122687

BLOOD CULTURE HOLDER by Greiner Bio-One North America, Inc. — Product Code JKA

K122687 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "BLOOD CULTURE HOLDER". The FDA issued a decision of Substantially Equivalent on January 10, 2013. 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 North America, Inc. has at least 9 other 510(k) clearances on record.