Cleared Traditional

NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K964491 · Unipath , Ltd. · Microbiology
Feb 1997
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K964491 is an FDA 510(k) clearance for the NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Unipath , Ltd. (Beverly, US). The FDA issued a Cleared decision on February 7, 1997, 92 days after receiving the submission on November 7, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K964491 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1996
Decision Date February 07, 1997
Days to Decision 92 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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