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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, Antigen, Control
510(k) Number K954723
Device Name ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
Applicant
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691 -6221
Applicant Contact VIRGINIA L CAPPEL
Correspondent
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691 -6221
Correspondent Contact VIRGINIA L CAPPEL
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received10/13/1995
Decision Date 12/15/1995
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
Recalls CDRH Recalls
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