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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Endomysial(Tissue Transglutaminase)
510(k) Number K002107
Device Name IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
Applicant
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Applicant Contact GARY LEHNUS,PH.D
Correspondent
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Correspondent Contact GARY LEHNUS,PH.D
Regulation Number866.5660
Classification Product Code
MVM  
Date Received07/12/2000
Decision Date 08/04/2000
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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