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FDA 510(k) Application Details - K041238
Device Classification Name
Campylobacter Pylori
More FDA Info for this Device
510(K) Number
K041238
Device Name
Campylobacter Pylori
Applicant
BIOHIT PLC
3535 ROUTE 66
BUILDING 4
NEPTUNE, NJ 07753 US
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Contact
ROBERT P GEARTY
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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
05/11/2004
Decision Date
12/13/2004
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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