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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 K112870
Device Name CLEARBLUE ADVANCED PREGNANCY TEST WITH WEEKS ESTIMATOR
Original Applicant
SPD Swiss Precision Diagnostics GmbH
priory business park
bedford,  GB mk44 3up
Original Contact louise roberts
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/30/2011
Decision Date 12/10/2012
Decision se - with limitations (SESU)
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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