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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 K920917
Device Name ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY
Applicant
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Applicant Contact BRUCE F WATKINS
Correspondent
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Correspondent Contact BRUCE F WATKINS
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received02/28/1992
Decision Date 03/26/1992
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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