Cleared Traditional

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

K073424 · Trek Diagnostic Systems, Inc. · Microbiology
Jan 2008
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K073424 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSCEPTIBILITY 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 January 22, 2008, 48 days after receiving the submission on December 5, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K073424 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2007
Decision Date January 22, 2008
Days to Decision 48 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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