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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 K012797
Device Name DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Applicant Contact LYNNE STIRLING
Correspondent
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Correspondent Contact LYNNE STIRLING
Regulation Number866.5750
Classification Product Code
MST  
Date Received08/21/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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