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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 K960091
FOIA Releasable 510(k) K960091
Device Name ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) 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
LRM  
Date Received01/11/1996
Decision Date 03/20/1996
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
Recalls CDRH Recalls
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