Cleared Traditional

BACTEC MGIT 960 SIRE KITS

K014123 · Becton, Dickinson & CO · Microbiology
Apr 2002
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K014123 is an FDA 510(k) clearance for the BACTEC MGIT 960 SIRE KITS, a Susceptibility Test Powders, Antimycobacterial (Class II — Special Controls, product code MJA), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on April 19, 2002, 123 days after receiving the submission on December 17, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K014123 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2001
Decision Date April 19, 2002
Days to Decision 123 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