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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K033067
Device Name PYLORI IGG
Applicant
Trinity Biotech USA
P.O. Box 1059
Jamestown,  NY  14702 -1059
Applicant Contact Bonnie B DeJoy
Correspondent
Trinity Biotech USA
P.O. Box 1059
Jamestown,  NY  14702 -1059
Correspondent Contact Bonnie B DeJoy
Regulation Number866.3110
Classification Product Code
LYR  
Date Received09/29/2003
Decision Date 11/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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