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FDA 510(k) Application Details - K972981
Device Classification Name
Campylobacter Pylori
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510(K) Number
K972981
Device Name
Campylobacter Pylori
Applicant
SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
DUNDEE DD2 1SW GB
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Contact
EILEEN MCCAFFERTY
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Regulation Number
866.3110
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Classification Product Code
LYR
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More FDA Info for this Product Code
Date Received
08/11/1997
Decision Date
03/17/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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