EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475— 510(k) K100060
Substantially EquivalentVital Diagnostics (Manufacturing) Ptyltd
FDA 510(k) clearance K100060 for EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475, Substantially Equivalent on 2010-12-15. Applicant: Vital Diagnostics (Manufacturing) Ptyltd.
Clearance details
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
- Product code
- Code KHS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noble Park, AU
Data sourced from openFDA. This site is unofficial and independent of the FDA.