SENSITITRE VIZION— 510(k) K081520

Substantially Equivalent

Trek Diagnostic Systems, Inc.

FDA 510(k) clearance K081520 for SENSITITRE VIZION, Substantially Equivalent on 2008-10-24. Applicant: Trek Diagnostic Systems, Inc..

Clearance details

Applicant: Trek Diagnostic Systems, Inc.
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2008-05-30
Decision date: 2008-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Cleveland, OH, US

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