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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 K872801
Device Name ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact B ASARCH,PHD
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact B ASARCH,PHD
Regulation Number866.5510
Classification Product Code
DGO  
Date Received07/15/1987
Decision Date 09/10/1987
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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