510(k) K860311
K860311 is an FDA 510(k) premarket notification submitted by Compagnie Oris Industrie, S.A. for the device "ACTHK-PR RIA KIT". The FDA issued a decision of Substantially Equivalent on April 7, 1986. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Compagnie Oris Industrie, S.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1986
- Date Received
- January 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type