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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K103487
Device Name FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
Applicant
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/26/2010
Decision Date 10/04/2011
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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