Clearance Summary
MedtFine Blood Lancet received FDA 510(k) clearance under submission number K221383, sponsored by Shanghai Carelife International Trading Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-09-21.
- Submission: K221383
- Applicant / Sponsor: Shanghai Carelife International Trading Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2022-09-21
Classification & Regulation
This clearance is catalogued under FDA product code QRK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.