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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 K041238
Device Name HELICOBACTER PYLORI IGG ELISA
Applicant
Biohit Plc
3535 Route 66
Bldg. 4
Neptune,  NJ  07753
Applicant Contact ROBERT P GEARTY
Correspondent
Biohit Plc
3535 Route 66
Bldg. 4
Neptune,  NJ  07753
Correspondent Contact ROBERT P GEARTY
Regulation Number866.3110
Classification Product Code
LYR  
Date Received05/11/2004
Decision Date 12/13/2004
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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