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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K892421
Device Name MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
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 Number866.5100
Classification Product Code
LJM  
Date Received04/10/1989
Decision Date 05/09/1989
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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