K171971

Substantially Equivalent

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer

Applicant: Lite-On Technology Corp. H.S.P.B.
Product code: CJE
Advisory panel: Clinical Chemistry
Date received: 2017-06-30
Decision date: 2018-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

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