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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 K013907
Device Name INVERNESS MEDICAL EARLY PREGNANCY TEST
Applicant
Cambridge Diagnostics Ireland, Ltd.
Mervue Business Park
Galway,  IE
Applicant Contact AVRIL MURRAY
Correspondent
Cambridge Diagnostics Ireland, Ltd.
Mervue Business Park
Galway,  IE
Correspondent Contact AVRIL MURRAY
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/26/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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