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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K862439
Device Name SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact JOHN G SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact JOHN G SIMPSON
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received06/26/1986
Decision Date 08/19/1986
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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