Clearance Summary
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 received FDA 510(k) clearance under submission number K032827, sponsored by Tyco Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2003-12-08.
- Submission: K032827
- Applicant / Sponsor: Tyco Healthcare
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9100
- Decision date: 2003-12-08
Classification & Regulation
This clearance is catalogued under FDA product code KSR and 21 CFR 864.9100, within the Hematology review panel as a Class II device.