510(k) K991702

MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 by Becton Dickinson Vacutainer Systems — Product Code JKA

K991702 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578". The FDA issued a decision of Substantially Equivalent on July 28, 1999. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.