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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 K150063
Device Name One Step hCG Pregnancy Test
Applicant
Coretests, Inc.
6190 Yarrow Dr.
Carlsbad,  CA  92011
Applicant Contact Wen Li
Correspondent
Coretests, Inc.
6190 Yarrow Dr.
Carlsbad,  CA  92011
Correspondent Contact Wen Li
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/13/2015
Decision Date 10/02/2015
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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