Cleared Traditional

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

K171971 · Lite-On Technology Corp. H.S.P.B. · Chemistry

Jan 2018

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K171971 is an FDA 510(k) clearance for the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Lite-On Technology Corp. H.S.P.B. (Hsinchu City, TW). The FDA issued a Cleared decision on January 25, 2018, 209 days after receiving the submission on June 30, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K171971 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2017
Decision Date	January 25, 2018
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF