VIZION— 510(k) K112276

Substantially Equivalent

Trek Diagnostic Systems

FDA 510(k) clearance K112276 for VIZION, Substantially Equivalent on 2011-11-16. Applicant: Trek Diagnostic Systems.

Clearance details

Applicant: Trek Diagnostic Systems
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2011-08-09
Decision date: 2011-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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