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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 K062703
Device Name ONE STEP HCG PREGNANCY TEST
Applicant
Ai DE Diagnostic Co., Ltd.
1929 Woodberry Ct.
Iowa City,  IA  52246
Applicant Contact LIN WANG
Correspondent
Ai DE Diagnostic Co., Ltd.
1929 Woodberry Ct.
Iowa City,  IA  52246
Correspondent Contact LIN WANG
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received09/11/2006
Decision Date 07/23/2007
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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