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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K863487
Device Name QUANTIMUNE(R) FERRITIN IRMA
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact FRANK MATARRESE
Regulation Number866.5340
Classification Product Code
DBF  
Date Received09/09/1986
Decision Date 10/01/1986
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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