The following data is part of a premarket notification filed by Qiagen, Inc. with the FDA for Ipsogen Jak2 Rgq Pcr Kit.
| Device ID | K172287 |
| 510k Number | K172287 |
| Device Name: | Ipsogen JAK2 RGQ PCR Kit |
| Classification | Jak2 Gene Mutation Detection Test |
| Applicant | QIAGEN, Inc. 19300 Germantown Road Germantown, MD 20874 |
| Contact | Lindsey Howard |
| Correspondent | Claire Ryan QIAGEN Manchester, Ltd. Skelton House, Lloyd Street North Manchester, GB M15 6sh |
| Product Code | PSU |
| CFR Regulation Number | 866.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2018-01-12 |
| Summary: | summary |