Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer— 510(k) K171971

Name: FDA 510(k) clearance K171971
Creator: U.S. Food and Drug Administration
Published: 2018-01-25

Substantially Equivalent

Lite-On Technology Corp. H.S.P.B.

FDA 510(k) clearance K171971 for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer, Substantially Equivalent on 2018-01-25. Applicant: Lite-On Technology Corp. H.S.P.B.. Device class: 2.

Clearance details

Applicant: Lite-On Technology Corp. H.S.P.B.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2017-06-30
Decision date: 2018-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

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