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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 K844158
Device Name STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact KAREN H DARAY
Correspondent
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact KAREN H DARAY
Regulation Number866.5340
Classification Product Code
DBF  
Date Received10/24/1984
Decision Date 11/19/1984
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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