510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911771Substantially Equivalent

Ard(tm) Antimicrobial Removal Device

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

K911771 is the FDA 510(k) clearance record for ARD(TM) ANTIMICROBIAL REMOVAL DEVICE, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code LJK (Antisera, If, Toxoplasma Gondii). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K911771.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LJK Antisera, If, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LJK

Trailing 12 months

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

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