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FDA 510(k) Application Details - DEN150030
Device Classification Name
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510(K) Number
DEN150030
Device Name
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
Applicant
KRONUS, INC.
170 S. SENECA SPRINGS WAY, SUITE 105
STAR, ID 83669 US
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BRIAN DEIS
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Regulation Number
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Classification Product Code
PNI
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Date Received
07/02/2015
Decision Date
04/25/2016
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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