FDA 510(k)

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

K-Number: K171971 · 2018-01-25

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

Decision Date2018-01-25

Product CodeCJE

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is a medical device manufactured by Lite-On Technology Corp. H.S.P.B.. It received FDA 510(k) clearance on 2018-01-25 under approval number K171971. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2018-01-25. It is manufactured by Lite-On Technology Corp. H.S.P.B.. The 510(k) number is K171971.

When was Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer approved by the FDA?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer received FDA 510(k) clearance on 2018-01-25, under approval number K171971.

What company makes Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is manufactured by Lite-On Technology Corp. H.S.P.B..

What is the FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is CJE.

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Official Source

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