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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
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