Clearance Summary
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT received FDA 510(k) clearance under submission number K801015, sponsored by Kimble-Terumo, 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 1980-05-14.
- Submission: K801015
- Applicant / Sponsor: Kimble-Terumo, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 1980-05-14
Classification & Regulation
This clearance is catalogued under FDA product code GIM and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.