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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K990035
Device Name RF
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 2020
Irving,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 2020
Irving,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number866.5775
Classification Product Code
DHR  
Date Received01/06/1999
Decision Date 03/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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