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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K860228
Device Name SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
Applicant
BOOTS-CELLTECH DIAGNOSTICS, INC.
240 BATH ROAD
SLOUGH SL1 4ET
BERKSHIRE, ENGLAND,  GB
Applicant Contact JOHN SIMPSON
Correspondent
BOOTS-CELLTECH DIAGNOSTICS, INC.
240 BATH ROAD
SLOUGH SL1 4ET
BERKSHIRE, ENGLAND,  GB
Correspondent Contact JOHN SIMPSON
Regulation Number862.1370
Classification Product Code
CFL  
Date Received01/22/1986
Decision Date 02/28/1986
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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