Clearance Summary
CHLORIDE/CARBON DIOXIDE RATE REAGENT received FDA 510(k) clearance under submission number K811701, 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 1981-07-01.
- Submission: K811701
- Applicant / Sponsor: Chem-Elec, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 1981-07-01
Classification & Regulation
This clearance is catalogued under FDA product code JFS and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.