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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Peroxidase, Antigen, Antiserum, Control
510(k) Number K860851
Device Name ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
Applicant
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Applicant Contact ELAINE WALTON
Correspondent
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Correspondent Contact ELAINE WALTON
Regulation Number866.5510
Classification Product Code
DGO  
Date Received03/07/1986
Decision Date 03/28/1986
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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