K220328
- 510(k) number
- K220328
- Device name
- EasyStat 300
- Applicant
- Medica Corporation MA · US
- Product code
- CGA — Glucose Oxidase, Glucose
- Decision date
- 2024-07-26
- Date received
- 2022-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K220328.pdf
Official FDA record: K220328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.