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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 K062096
Device Name KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
Applicant
Koreamedico Co. , Ltd.
2f, 839-9 Hwagok-4-Dong,
Gangseo-Gu
Seoul,  KR 157-902
Applicant Contact KIM YOUNG-YONG
Correspondent
Koreamedico Co. , Ltd.
2f, 839-9 Hwagok-4-Dong,
Gangseo-Gu
Seoul,  KR 157-902
Correspondent Contact KIM YOUNG-YONG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received07/24/2006
Decision Date 05/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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