Clearance Summary
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 received FDA 510(k) clearance under submission number K042362, sponsored by Diagnostic Chemicals , 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 2004-12-27.
- Submission: K042362
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1160
- Decision date: 2004-12-27
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.