510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951542Substantially Equivalent

Directigen 1-2-3 Group a Strep Test

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

K951542 is the FDA 510(k) clearance record for DIRECTIGEN 1-2-3 GROUP A STREP TEST, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code GTZ (Antisera, All Groups, Streptococcus Spp.). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K951542.

Clearance record

Decision date
Received
(200 days to decision)
Product code
GTZ Antisera, All Groups, Streptococcus Spp.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic P.O. Box 987, Columbus NE
510(k) summary
Summary
Third party review
No

Clearances, product code GTZ

Trailing 12 months

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

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