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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K984478
Device Name LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
Applicant
Bio-Rad
9500 Jeronimo Rd.
Ivrvine,  CA  92618
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Ivrvine,  CA  92618
Correspondent Contact ELIZABETH PLATT
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received12/16/1998
Decision Date 12/22/1998
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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