510(k) DEN150030
- Device
- KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- Applicant
- Kronus, Inc.
- 510(k) number
- DEN150030
- Product code
- PNI
- Decision
- Unknown (DENG)
- Decision date
- 2016-04-25
- Date received
- 2015-07-02
- Regulation
- 866.5665
- Classification name
- Aquaporin-4 Autoantibody
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- BRIAN DEIS
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 3003834021
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PNI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-07-22 |