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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 K780870
Device Name RIA SYSTEM FOR HUMAN F-S HORMONE
Applicant
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received05/30/1978
Decision Date 06/22/1978
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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