Medical Device Manufacturer · US , Gernmantown , MD

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

2 submissions · 1 cleared · Since 2017

Recent clearances: ipsogen JAK2 RGQ PCR Kit

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Qiagen, Inc. Pathology ✕

2 devices

1-2 of 2

Cleared Jan 12, 2018

ipsogen JAK2 RGQ PCR Kit

Pathology · 168d

Not Cleared Mar 27, 2017

ipsogen JAK2 RGQ PCR Kit

DEN160028 · PSU

Pathology · 269d

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 09, 2026