510(k) K902609

DIRECTIGEN FLU A by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GNT

K902609 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DIRECTIGEN FLU A". The FDA issued a decision of Substantially Equivalent on September 10, 1990. The device falls under product code GNT (Antigens, Ha (Including Ha Control), Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.