510(k) K161951
- Device
- KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- Applicant
- KRONUS, INC.
- 510(k) number
- K161951
- Product code
- PNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-22
- Date received
- 2016-07-15
- Regulation
- 866.5665
- Classification name
- Aquaporin-4 Autoantibody
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
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 |
|---|---|---|---|
| DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-04-25 |
Legacy Summary#
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FDA Review#
Decision Summary