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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K771771
Device Name QUAN. COLOR. DETER. OF SERUM ALBUMIN
Applicant
STANBIO LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STANBIO LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5040
Classification Product Code
DCF  
Date Received09/19/1977
Decision Date 10/07/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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