Cleared Traditional

VIZION

K112276 · Trek Diagnostic Systems · Microbiology
Nov 2011
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K112276 is an FDA 510(k) clearance for the VIZION, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on November 16, 2011, 99 days after receiving the submission on August 9, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K112276 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2011
Decision Date November 16, 2011
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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