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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 K871332
Device Name CLEARPLAN
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact GEORGE ZAJICEK
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact GEORGE ZAJICEK
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/03/1987
Decision Date 08/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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