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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K000755
Device Name RHIGENE MESACUP2 TEST- SM
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 Number866.5100
Classification Product Code
LKP  
Date Received03/08/2000
Decision Date 05/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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