SENSITITRE AIM (TM)— 510(k) K110331

Substantially Equivalent

Trek Diagnostic Systems, Ltd.

FDA 510(k) clearance K110331 for SENSITITRE AIM (TM), Substantially Equivalent on 2011-04-27. Applicant: Trek Diagnostic Systems, Ltd..

Clearance details

Applicant: Trek Diagnostic Systems, Ltd.
Product code: Code LIE
Advisory panel: Microbiology
Date received: 2011-02-03
Decision date: 2011-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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