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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K171971
Device Name Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
Applicant
Lite-On Technology Corp. H.S.P.B.
8, Dusing Rd., Hsinchu Science Park
Hsinchu City,  TW 30078
Applicant Contact John Lo
Correspondent
Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant
29222 Rancho Viejo Rd.
Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1050
Classification Product Code
CJE  
Subsequent Product Codes
CDN   CGX   CIT   CKA   JJG  
Date Received06/30/2017
Decision Date 01/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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