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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
510(k) Number K000336
Device Name RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
Applicant
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Applicant Contact DAVE KOLESAR
Correspondent
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Correspondent Contact DAVE KOLESAR
Regulation Number866.5660
Classification Product Code
NBO  
Date Received02/03/2000
Decision Date 06/09/2000
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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