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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 K892706
Device Name SR1 (FSH) IMMUNOENZYMETRIC ASSAY
Applicant
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Applicant Contact TOMALESKY, PHD
Correspondent
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Correspondent Contact TOMALESKY, PHD
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received04/14/1989
Decision Date 06/09/1989
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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