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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 K022018
Device Name RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
Applicant
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Applicant Contact YUSUKE KOBE
Correspondent
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Correspondent Contact YUSUKE KOBE
Regulation Number866.5100
Classification Product Code
LJM  
Date Received06/20/2002
Decision Date 07/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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