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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 K955134
Device Name ORGENTEC ENASCREEN ELISA ASSAY
Applicant
Orgentec
P.O. Box 451
Windham,  NH  03087
Applicant Contact RICHARD CONLEY
Correspondent
Orgentec
P.O. Box 451
Windham,  NH  03087
Correspondent Contact RICHARD CONLEY
Regulation Number866.5100
Classification Product Code
LLL  
Date Received11/09/1995
Decision Date 03/20/1996
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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