Cleared Traditional

GATIFLOXACIN, 5 UG, BBL SENSI-DISC

K000829 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Apr 2000
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K000829 is an FDA 510(k) clearance for the GATIFLOXACIN, 5 UG, BBL SENSI-DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on April 13, 2000, 30 days after receiving the submission on March 14, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K000829 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2000
Decision Date April 13, 2000
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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