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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K033528
Device Name MESACUP-2 TEST JO-1, MODEL 10756
Applicant
Rhigene, Inc.
12061 Tejon St.
Westminster,  CO  80234
Applicant Contact NANCI DEXTER
Correspondent
Rhigene, Inc.
12061 Tejon St.
Westminster,  CO  80234
Correspondent Contact NANCI DEXTER
Regulation Number866.5100
Classification Product Code
LLL  
Date Received11/07/2003
Decision Date 12/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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