Cleared Traditional

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE

K911771 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Jul 1991
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K911771 is an FDA 510(k) clearance for the ARD(TM) ANTIMICROBIAL REMOVAL DEVICE, a Antisera, If, Toxoplasma Gondii (Class II — Special Controls, product code LJK), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 1, 1991, 73 days after receiving the submission on April 19, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K911771 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1991
Decision Date July 01, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJK — Antisera, If, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780