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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, Systemic Lupus Erythematosus
510(k) Number K885048
Device Name ACCESS R-CLONE ANA PROFILE ASSAY
Applicant
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Applicant Contact DEES, PH.D.
Correspondent
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Correspondent Contact DEES, PH.D.
Regulation Number866.5820
Classification Product Code
DHC  
Date Received12/07/1988
Decision Date 01/24/1989
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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