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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name visual, pregnancy hcg, prescription use
510(k) Number K112315
Device Name HOME PREGNANCY TEST
Applicant
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
2117 CLANEY CT
SIMI VALLEY,  CA  93065
Applicant Contact CHANDRAVADAN PATEL
Correspondent
NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD
2117 CLANEY CT
SIMI VALLEY,  CA  93065
Correspondent Contact CHANDRAVADAN PATEL
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/11/2011
Decision Date 04/23/2012
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
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