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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K981271
Device Name CLEARPLAN EASY OVULATION TEST
Applicant
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Applicant Contact Louise Roberts
Correspondent
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Correspondent Contact Louise Roberts
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/07/1998
Decision Date 06/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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