Clearance Summary
BICARBONATE (CO2) REAGENT-2 VIAL received FDA 510(k) clearance under submission number K881938, sponsored by Trace Scientific , Ltd.. 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 1988-06-15.
- Submission: K881938
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 1988-06-15
Classification & Regulation
This clearance is catalogued under FDA product code KHS and 21 CFR 862.1160, within the Clinical Chemistry review panel as a Class II device.