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FDA 510(k) Applications Submitted by ASURAGEN, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
DEN190023
04/18/2019
AmplideX Fragile X Dx & Carrier Screen Kit
Asuragen, Inc.
DEN160003
01/19/2016
Quantidex qPCR BCR-ABL IS Kit
ASURAGEN, INC.
K113420
11/18/2011
RNARETAIN
ASURAGEN, INC.
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