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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Rnp Antibody, Antigen And Control
510(k) Number K874152
Device Name RNP ANTIBODY TEST KIT
Applicant
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Applicant Contact MICHAEL FOUNTAIN,PHD
Correspondent
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Correspondent Contact MICHAEL FOUNTAIN,PHD
Regulation Number866.5100
Classification Product Code
LKO  
Date Received10/13/1987
Decision Date 03/11/1988
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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