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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K000489
Device Name ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
Applicant
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691 -6221
Applicant Contact VIRGINIA CAPPEL
Correspondent
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691 -6221
Correspondent Contact VIRGINIA CAPPEL
Regulation Number866.5100
Classification Product Code
LLL  
Date Received02/14/2000
Decision Date 04/05/2000
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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