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FDA 510(k) Application Details - DEN170045
Device Classification Name
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510(K) Number
DEN170045
Device Name
Banyan BTI
Applicant
Banyan Biomarkers, Inc.
16470 West Bernardo Drive
Suite 100
San Diego, CA 92127 US
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Contact
Steven P. Richieri
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Regulation Number
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Classification Product Code
QAT
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Date Received
08/28/2017
Decision Date
02/14/2018
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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