The following data is part of a premarket notification filed by Compagnie Oris Industrie, S.a. with the FDA for Acthk-pr Ria Kit.
| Device ID | K860311 |
| 510k Number | K860311 |
| Device Name: | ACTHK-PR RIA KIT |
| Classification | Radioimmunoassay, Acth |
| Applicant | COMPAGNIE ORIS INDUSTRIE, S.A. C/O CIS-US, INC. 1983 MARCUS AVENUE Lake Success, NY 11042 |
| Contact | Michael D Garret |
| Correspondent | Michael D Garret COMPAGNIE ORIS INDUSTRIE, S.A. C/O CIS-US, INC. 1983 MARCUS AVENUE Lake Success, NY 11042 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-04-07 |