ipsogen JAK2 RGQ PCR Kit
FDA 510(k) clearance K172287 · decided 2018-01-12
Clearance details
- K-number
- K172287
- Device name
- ipsogen JAK2 RGQ PCR Kit
- Applicant
- Qiagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-28
- Decision date
- 2018-01-12
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- PSU
- Device class
- 2
- Regulation number
- 866.6070
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Germantown, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PartoSure Test (P160052/S001) | Qiagen, Inc. | 2019-10-11 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit (P130027/S006) | Qiagen, Inc. | 2018-09-26 |
| PartoSure test (P160052) | Qiagen, Inc. | 2018-04-11 |
| artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit (P130027/S005) | Qiagen, Inc. | 2018-04-06 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit (P130027/S004) | Qiagen, Inc. | 2018-03-13 |
| Artus CMV RGQ and QS-RGQ MDx Kit (P130027/S003) | Qiagen, Inc. | 2017-11-15 |
| ARTUS CMV RGQ MDX KIT (P130027/S002) | Qiagen, Inc. | 2017-06-02 |
| ARTUS CMV RGQ MDX KIT (P130027/S001) | Qiagen, Inc. | 2015-07-09 |