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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K181915
Device Name PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Applicant
iXensor Co., LTD.
6F., No.9 Aly. 2, Ln. 35, Jihu Road. Neihu Dist.
Taipei,  TW 114
Applicant Contact Ariel Huang
Correspondent
IVDD Regulatory Consultant
29222 Rancho Viejo Rd., Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJE  
Date Received07/17/2018
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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