Asuragen, Inc.

FDA Regulatory Profile

Asuragen, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 21, 2020.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN190023AmplideX Fragile X Dx & Carrier Screen KitFebruary 21, 2020
DEN160003Quantidex qPCR BCR-ABL IS KitJuly 22, 2016
K113420RNARETAINMarch 16, 2012