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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 K112449
Device Name QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
Original Applicant
TIANJIN NEW BAY BIORESEARCH CO., LTD.
5230 via primaria
yorba linda,  CA  92886
Original Contact hann-ping wang
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/25/2011
Decision Date 09/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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