The following data is part of a premarket notification filed by Kronus, Inc. with the FDA for Steroid 21-hydroxylase Antibody (21-ohab) Elisa Kit.
| Device ID | K180607 |
| 510k Number | K180607 |
| Device Name: | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit |
| Classification | 21-hydroxylase Antibody (21-ohab) |
| 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 | PCG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-07 |
| Decision Date | 2018-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B126KR70150 | K180607 | 000 |