EasyStat 300
FDA 510(k) clearance K220328 · decided 2024-07-26
Clearance details
- K-number
- K220328
- Device name
- EasyStat 300
- Applicant
- Medica Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-02-04
- Decision date
- 2024-07-26
- Days to decision
- 903 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.