510(k) K172287
- Device
- Ipsogen JAK2 RGQ PCR Kit
- Applicant
- QIAGEN, Inc.
- 510(k) number
- K172287
- Product code
- PSU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-12
- Date received
- 2017-07-28
- Regulation
- 866.6070
- Classification name
- Jak2 Gene Mutation Detection Test
- Medical specialty
- Molecular Genetics
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lindsey Howard
- Address
- 19300 Germantown Rd. Germantown MD US 20874 20874
FDA Registration Numbers#
- 3004013603
Source Documents#
Other 510(k) Records For Product Code PSU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2017-03-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary