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 |