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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 K142664
Device Name URight Hemoglobin A1c system, FORA A1c System
Applicant
TAIDOC TECHNOLOGY CORPORATION
B1-7F , No.127, Wugong 2nd Rd., Wugu District
New Taipei City,  TW 24888
Applicant Contact C.W. Chen
Correspondent
TaiDoc Technology Corporation
6F, No. 127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact Paul Liu
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JJE   JJX  
Date Received09/18/2014
Decision Date 01/29/2016
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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