510(k) K063357

MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES by Greiner Bio-One North America, Inc. — Product Code JKA

K063357 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES". The FDA issued a decision of Substantially Equivalent on July 10, 2007. 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.