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FDA 510(k) Application Details - DEN190023
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN190023
Device Name
AmplideX Fragile X Dx & Carrier Screen Kit
Applicant
Asuragen, Inc.
2150 Woodward, Suite 100
Austin, TX 78744 US
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Contact
Bernard Andruss
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OYV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2019
Decision Date
02/21/2020
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MG -
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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