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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K951850
Device Name ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
Applicant
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691
Applicant Contact VIRGINIA L CAPPEL
Correspondent
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691
Correspondent Contact VIRGINIA L CAPPEL
Regulation Number866.5100
Classification Product Code
LJM  
Date Received04/21/1995
Decision Date 07/18/1995
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
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