Cleared Traditional

SENSITITRE OPTIREAD

K110583 · Trek Diagnostic Systems, Ltd. · Microbiology
Sep 2011
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K110583 is an FDA 510(k) clearance for the SENSITITRE OPTIREAD, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on September 22, 2011, 205 days after receiving the submission on March 1, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K110583 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2011
Decision Date September 22, 2011
Days to Decision 205 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

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