510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902609Substantially Equivalent

Directigen Flu a

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902609 is the FDA 510(k) clearance record for DIRECTIGEN FLU A, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code GNT (Antigens, Ha (Including Ha Control), Influenza Virus A, B, C). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K902609.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code GNT

Trailing 12 months

FDA records hold no clearances under product code GNT in the trailing twelve months.

FDA records show no clearances under product code GNT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260