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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 K972981
Device Name SHIELD HELICO-G2 ELISA KIT
Applicant
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Applicant Contact EILEEN MCCAFFERTY
Correspondent
Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1SW
Correspondent Contact EILEEN MCCAFFERTY
Regulation Number866.3110
Classification Product Code
LYR  
Date Received08/11/1997
Decision Date 03/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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