Cleared Traditional

SENSITITRE AIM (TM)

K110331 · Trek Diagnostic Systems, Ltd. · Microbiology
Apr 2011
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K110331 is an FDA 510(k) clearance for the SENSITITRE AIM (TM), a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on April 27, 2011, 83 days after receiving the submission on February 3, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K110331 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2011
Decision Date April 27, 2011
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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