Cleared Traditional

TROVAFLOXACIN 10G, SENSI-DISC

K980683 · Becton Dickinson Microbiology Systems · Microbiology
May 1998
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K980683 is an FDA 510(k) clearance for the TROVAFLOXACIN 10G, SENSI-DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on May 1, 1998, 67 days after receiving the submission on February 23, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K980683 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1998
Decision Date May 01, 1998
Days to Decision 67 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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