Cleared Traditional

BACTEC MGIT 960 SIR KITS

K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Jun 2001
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K003062 is an FDA 510(k) clearance for the BACTEC MGIT 960 SIR KITS, a Susceptibility Test Powders, Antimycobacterial (Class II — Special Controls, product code MJA), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on June 6, 2001, 247 days after receiving the submission on October 2, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K003062 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2000
Decision Date June 06, 2001
Days to Decision 247 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJA — Susceptibility Test Powders, Antimycobacterial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640