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FDA 510(k) Application Details - K210976
Device Classification Name
Campylobacter Spp.
More FDA Info for this Device
510(K) Number
K210976
Device Name
Campylobacter Spp.
Applicant
Meridian Bioscience, Inc.
3471 River Hills Drive
Cincinnati, OH 45244 US
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Contact
Heather Planck
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Regulation Number
866.3110
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Classification Product Code
LQP
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More FDA Info for this Product Code
Date Received
04/01/2021
Decision Date
12/23/2021
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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