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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Gliadin
510(k) Number K002189
Device Name GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
Applicant
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Applicant Contact GARY L EHNUS
Correspondent
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Correspondent Contact GARY L EHNUS
Regulation Number866.5750
Classification Product Code
MST  
Date Received07/19/2000
Decision Date 10/19/2000
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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