Clearance Summary
SORVALL RT6000 REFRIGERATED TABLETOP received FDA 510(k) clearance under submission number K810833, sponsored by E.I. Dupont DE Nemours & Co., 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 1981-04-08.
- Submission: K810833
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1981-04-08
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.