Clearance Summary
CHEMO-SPIKE II RECONSTITUTION DEVICE received FDA 510(k) clearance under submission number K974431, sponsored by Medi-Dose, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-01-08.
- Submission: K974431
- Applicant / Sponsor: Medi-Dose, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1998-01-08
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.