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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 K990587
Device Name ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact ELIZABETH PLATT
Regulation Number866.5775
Classification Product Code
DHR  
Date Received02/23/1999
Decision Date 04/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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