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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K880254
Device Name SM ANTIBODY TEST KIT
Applicant
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Applicant Contact W FOUNTAIN
Correspondent
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Correspondent Contact W FOUNTAIN
Regulation Number866.5100
Classification Product Code
LKP  
Date Received01/20/1988
Decision Date 04/06/1988
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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