510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132456Substantially Equivalent

Bd Veritor (Tm) System for Rapid Detection of Rsv

Becton Dickinson & Co, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132456 is the FDA 510(k) clearance record for BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV, a class I device, cleared for Becton, Dickinson and Company on under FDA product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus). FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show no recalls naming K132456.

Clearance record

Decision date
Received
(93 days to decision)
Product code
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Becton, Dickinson and Company 10865 Rd. To The Cure,, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GQG

Trailing 12 months
1 clearance under product code GQG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260