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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3b Activator Immunoassay Reagents
510(k) Number K790059
Device Name PROACTIVATOR C3, C4 AND C3
Applicant
Icl Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Icl Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5260
Classification Product Code
KTP  
Date Received01/09/1979
Decision Date 03/15/1979
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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