Clearance Summary
ACTIVATOR received FDA 510(k) clearance under submission number K790346, sponsored by Tri-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-03-21.
- Submission: K790346
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7140
- Decision date: 1979-03-21
Classification & Regulation
This clearance is catalogued under FDA product code JBP and 21 CFR 864.7140, within the Hematology review panel as a Class II device.