510(k) K770655

LATELET DETERMIBATION KIT, UL 800 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJP

K770655 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "LATELET DETERMIBATION KIT, UL 800". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code GJP (Control, Platelet), a Class II device regulated under 21 CFR 864.8625. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.