510(k) K863491

BLOOD SPECIMEN COLLECTION DEVICES by Medelec Intl. Corp. — Product Code JKA

K863491 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "BLOOD SPECIMEN COLLECTION DEVICES". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.