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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gamma Globulin, Antigen, Antiserum, Control
510(k) Number K854944
Device Name TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Applicant Contact KEITH MINTER
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Correspondent Contact KEITH MINTER
Regulation Number866.5510
Classification Product Code
DAH  
Date Received12/10/1985
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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