Cleared Special

SENSITITRE VIZION

K081520 · Trek Diagnostic Systems, Inc. · Microbiology
Oct 2008
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K081520 is an FDA 510(k) clearance for the SENSITITRE VIZION, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 24, 2008, 147 days after receiving the submission on May 30, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K081520 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2008
Decision Date October 24, 2008
Days to Decision 147 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

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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