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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K871144
Device Name TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
Applicant
Vitrotec Laboratories, Inc.
5245 Avenida Encinas, Suite C
Carlsbad,  CA  92008
Applicant Contact KEVIN BICKFORD
Correspondent
Vitrotec Laboratories, Inc.
5245 Avenida Encinas, Suite C
Carlsbad,  CA  92008
Correspondent Contact KEVIN BICKFORD
Regulation Number866.5100
Classification Product Code
DHN  
Date Received03/23/1987
Decision Date 04/29/1987
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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