510(k) DEN160028
- Device
- ipsogen JAK2 RGQ PCR Kit
- Applicant
- Qiagen, Inc.
- 510(k) number
- DEN160028
- Product code
- PSU
- Decision
- Unknown (DENG)
- Decision date
- 2017-03-27
- Date received
- 2016-07-01
- Regulation
- 866.6070
- Classification name
- Jak2 Gene Mutation Detection Test
- Medical specialty
- Medical Genetics
- Review panel
- Medical Genetics
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- LINDSEY HOWARD
- Address
- 19300 Germantown Rd. Germantown MD US 20874 20874
FDA Registration Numbers#
- 3004013603
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PSU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172287 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2018-01-12 |