Clearance Summary
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE received FDA 510(k) clearance under submission number K944738, sponsored by Ducker CL. 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 1994-10-19.
- Submission: K944738
- Applicant / Sponsor: Ducker CL
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1994-10-19
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.