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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 K780347
Device Name RIA SYS. FOR HUMAN GROWTH 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 Number862.1370
Classification Product Code
CFL  
Date Received03/02/1978
Decision Date 04/12/1978
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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