KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
FDA 510(k) clearance DEN150030 · decided 2016-04-25
Clearance details
- K-number
- DEN150030
- Device name
- KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- Applicant
- Kronus, Inc.
- Decision
- Unknown
- Date received
- 2015-07-02
- Decision date
- 2016-04-25
- Days to decision
- 298 days
- Clearance type
- Direct
- Product code
- PNI
- Device class
- 2
- Regulation number
- 866.5665
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Star, ID, 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 |
|---|---|---|
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (K161951) | Kronus, Inc. | 2016-07-22 |
Recalls involving this device
No recalls on record reference this clearance.