Clearance Summary
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder received FDA 510(k) clearance under submission number K163073, sponsored by Sol-Millennium Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2017-05-19.
- Submission: K163073
- Applicant / Sponsor: Sol-Millennium Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2017-05-19
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.