Cleared Traditional

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K053243 · Trek Diagnostic Systems, Inc. · Microbiology

Jan 2006

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K053243 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on January 20, 2006, 60 days after receiving the submission on November 21, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K053243 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2005
Decision Date	January 20, 2006
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640