AUTOREADER 2— 510(k) K103532

Substantially Equivalent

Trek Diagnostic Systems

FDA 510(k) clearance K103532 for AUTOREADER 2, Substantially Equivalent on 2011-08-26. Applicant: Trek Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Trek Diagnostic Systems
Product code: Code LRG
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2010-12-01
Decision date: 2011-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.