Clearance Summary
MICRO HAEMATOCRIT CENTRIFUGE received FDA 510(k) clearance under submission number K960491, sponsored by Hawksley & Sons , Ltd.. 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 1996-10-18.
- Submission: K960491
- Applicant / Sponsor: Hawksley & Sons , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1025
- Decision date: 1996-10-18
Classification & Regulation
This clearance is catalogued under FDA product code CKG and 21 CFR 862.1025, within the Clinical Chemistry review panel as a Class II device.