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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
Applicant Contact VIRGINIA CAPPEL
Correspondent
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691
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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