510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952791Substantially Equivalent

Directigen Meningitis Combo Test

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

K952791 is the FDA 510(k) clearance record for DIRECTIGEN MENINGITIS COMBO TEST, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code GTJ (Antisera, All Groups, N. Meningitidis). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K952791.

Clearance record

Decision date
Received
(346 days to decision)
Product code
GTJ Antisera, All Groups, N. Meningitidis
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic P.O. Box 243, Cockeysville MD
510(k) summary
Summary
Third party review
No

Clearances, product code GTJ

Trailing 12 months

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

FDA records show no clearances under product code GTJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GTJ, 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