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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 Indirect Immunofluorescent Solid Phase
510(k) Number K864275
Device Name ANTI-NDNA ANTIBODY TEST KIT
Applicant
Cappel Diagnostics, Inc.
P.O. Box 4027
Davis,  CA  95617
Applicant Contact VIRGINIA CAPPEL
Correspondent
Cappel Diagnostics, Inc.
P.O. Box 4027
Davis,  CA  95617
Correspondent Contact VIRGINIA CAPPEL
Regulation Number866.5100
Classification Product Code
KTL  
Date Received10/29/1986
Decision Date 12/15/1986
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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