Cleared Traditional

SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

K083606 · Trek Diagnostic Systems, Inc. · Microbiology
Mar 2009
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K083606 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES, 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 March 24, 2009, 109 days after receiving the submission on December 5, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K083606 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2008
Decision Date March 24, 2009
Days to Decision 109 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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