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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 K880758
Device Name SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
Applicant
BOOTS-CELLTECH DIAGNOSTICS, INC.
240 BATH ROAD
SLOUGH SL1 4ET
BERKSHIRE, ENGLAND,  GB
Applicant Contact STEPHEN R ABBOTT
Correspondent
BOOTS-CELLTECH DIAGNOSTICS, INC.
240 BATH ROAD
SLOUGH SL1 4ET
BERKSHIRE, ENGLAND,  GB
Correspondent Contact STEPHEN R ABBOTT
Regulation Number862.1485
Classification Product Code
CEP  
Date Received02/25/1988
Decision Date 04/18/1988
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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