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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K954814
Device Name ORGENTEC ANTI-SCL 70 PIN IMMUNO 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
LJM  
Date Received10/19/1995
Decision Date 04/18/1996
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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