ONE DROP Lancing Device
FDA 510(k) clearance K223815 · decided 2023-02-15
Clearance details
- K-number
- K223815
- Device name
- ONE DROP Lancing Device
- Applicant
- Stat Medical Devices
- Decision
- Substantially Equivalent
- Date received
- 2022-12-20
- Decision date
- 2023-02-15
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- QRK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Miami Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.