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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
Recalls CDRH Recalls
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