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FDA 510(k) Application Details - K110745
Device Classification Name
Campylobacter Pylori
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510(K) Number
K110745
Device Name
Campylobacter Pylori
Applicant
GOLD STANDARD DIAGNOSTICS
2851 SPAFFORD
Davis, CA 95618 US
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Contact
NAPOLEON MONCE
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
03/17/2011
Decision Date
03/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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