Clearance Summary
CENTRIFUGES received FDA 510(k) clearance under submission number K840768, sponsored by Heraeus-Christ GmbH. 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 1984-05-07.
- Submission: K840768
- Applicant / Sponsor: Heraeus-Christ GmbH
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1984-05-07
Classification & Regulation
This clearance is catalogued under FDA product code JQC and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.