FDA Product Code
FDA Product Code PSU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Medical Genetics
- 21 CFR Citation
- 866.6070
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172287 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2018-01-12 | Traditional | PDF ↗ |
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2017-03-27 | Direct | — |
Product code PSU · Class II · Medical Genetics. Data: openFDA.