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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 K011068
Device Name RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
Applicant
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Applicant Contact DAVID KOLESAR
Correspondent
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Correspondent Contact DAVID KOLESAR
Regulation Number866.5100
Classification Product Code
KTL  
Date Received04/09/2001
Decision Date 04/11/2002
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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