Medical Device Manufacturer · US , Austin , TX

Asuragen, Inc. - FDA 510(k) Cleared Devices

3 submissions · 1 cleared · Since 2012

Official Website

3

Total

1

Cleared

2

Denied

FDA 510(k) Regulatory Record - Asuragen, Inc. Medical Genetics ✕

2 devices

1-2 of 2

Not Cleared Feb 21, 2020

AmplideX Fragile X Dx & Carrier Screen Kit

DEN190023 · OYV

Medical Genetics · 309d

Not Cleared Jul 22, 2016

Quantidex qPCR BCR-ABL IS Kit

DEN160003 · OYX

Medical Genetics · 185d