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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K855046
Device Name TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
Applicant
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Applicant Contact BARBARA BOOKER
Correspondent
ABBOTT LABORATORIES
1921 HURD DR.
P.O.BOX 152020
IRVING,  TX  75015 -2020
Correspondent Contact BARBARA BOOKER
Regulation Number866.5510
Classification Product Code
CZP  
Date Received12/17/1985
Decision Date 08/27/1986
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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