Cleared Traditional

DISPENS-O-DISC (TM) LEVOFLOXACIN

K971120 · Difco Laboratories, Inc. · Microbiology
Apr 1997
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K971120 is an FDA 510(k) clearance for the DISPENS-O-DISC (TM) LEVOFLOXACIN, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on April 14, 1997, 18 days after receiving the submission on March 27, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K971120 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1997
Decision Date April 14, 1997
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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