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FDA 510(k) Application Details - K191456
Device Classification Name
Campylobacter Spp.
More FDA Info for this Device
510(K) Number
K191456
Device Name
Campylobacter Spp.
Applicant
Techlab, Inc
2001 Kraft Drive
Blacksburg, VA 24085 US
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Contact
Donna Link
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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
05/31/2019
Decision Date
06/20/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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