Clearance Summary
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH received FDA 510(k) clearance under submission number K072783, sponsored by Smiths Medical Asd, 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 2007-11-30.
- Submission: K072783
- Applicant / Sponsor: Smiths Medical Asd, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2007-11-30
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.