The following data is part of a premarket notification filed by Kronus, Inc. with the FDA for Kronus Aquaporin-4 Autoantibody (aqp4ab) Elisa Assay.
| Device ID | K161951 |
| 510k Number | K161951 |
| Device Name: | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay |
| Classification | Aquaporin-4 Autoantibody |
| Applicant | KRONUS, INC. 170 S. SENECA SPRINGS WAY, SUITE 105 Star, ID 83669 |
| Contact | Brian Deis |
| Correspondent | Brian Deis KRONUS, INC. 170 S. SENECA SPRINGS WAY, SUITE 105 Star, ID 83669 |
| Product Code | PNI |
| CFR Regulation Number | 866.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-15 |
| Decision Date | 2016-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR82000 | K161951 | 000 |