Clearance Summary
MULTIDRAW SYSTEM received FDA 510(k) clearance under submission number K922858, sponsored by Cambridge Multi-Draw, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1992-11-16.
- Submission: K922858
- Applicant / Sponsor: Cambridge Multi-Draw, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 1992-11-16
Classification & Regulation
This clearance is catalogued under FDA product code GIM and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.