510(k) K771370

ICROTAINEO BRAND TUBE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJE

K771370 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ICROTAINEO BRAND TUBE". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.