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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K001900
Device Name ENZYME IMMUNOASSAY ANTI-SSDNA 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
LRM  
Date Received06/22/2000
Decision Date 09/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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