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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 K110433
Device Name CLEARBLUE EASY PREGNANCY TEST
Applicant
SPD Development Company Limited
Stannard Way
Priory Business Park
Bedford, Bedfordshire,  GB MK44 3UP
Applicant Contact TANYA FAIR
Correspondent
SPD Development Company Limited
Stannard Way
Priory Business Park
Bedford, Bedfordshire,  GB MK44 3UP
Correspondent Contact TANYA FAIR
Regulation Number862.1155
Classification Product Code
LCX  
Date Received02/15/2011
Decision Date 05/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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