Clearance Summary
BUN RATE REAGENT received FDA 510(k) clearance under submission number K811193, sponsored by Chem-Elec, 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 1981-07-10.
- Submission: K811193
- Applicant / Sponsor: Chem-Elec, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1981-07-10
Classification & Regulation
This clearance is catalogued under FDA product code CDS and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.