The following data is part of a premarket notification filed by Kronus, Inc. with the FDA for Kronus Ia-2 Autoantibody (ia-2ab) Elisa Kit.
| Device ID | K171731 |
| 510k Number | K171731 |
| Device Name: | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit |
| Classification | Tyrosine Phosphatase (ia-2) Autoantibody Assay |
| 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 | OIF |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2018-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR77550 | K171731 | 000 |