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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K862821
Device Name CAPPEL DIAGNOSTICS ANA KIT
Applicant
Cappel Diagnostics, Inc.
P.O. Box 4027
Davis,  CA  95617
Applicant Contact LIPP CAPPEL
Correspondent
Cappel Diagnostics, Inc.
P.O. Box 4027
Davis,  CA  95617
Correspondent Contact LIPP CAPPEL
Regulation Number866.5100
Classification Product Code
DHN  
Date Received07/25/1986
Decision Date 08/15/1986
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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