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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K944191
Device Name ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
Applicant
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact ANDRAS PETER
Correspondent
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact ANDRAS PETER
Regulation Number866.5660
Classification Product Code
DBL  
Date Received08/29/1994
Decision Date 03/06/1995
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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