Cleared Traditional

SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL

K060783 · Trek Diagnostic Systems, Inc. · Microbiology
May 2006
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K060783 is an FDA 510(k) clearance for the SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL, 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 May 16, 2006, 55 days after receiving the submission on March 22, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K060783 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2006
Decision Date May 16, 2006
Days to Decision 55 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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