Clearance Summary
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 received FDA 510(k) clearance under submission number K100060, sponsored by Vital Diagnostics (Manufacturing) Ptyltd. 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 2010-12-15.
- Submission: K100060
- Applicant / Sponsor: Vital Diagnostics (Manufacturing) Ptyltd
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 2010-12-15
Classification & Regulation
This clearance is catalogued under FDA product code KHS and 21 CFR 862.1160, within the Clinical Chemistry review panel as a Class II device.