Clearance Summary
CamAPS FX received FDA 510(k) clearance under submission number K232603, sponsored by Camdiab , 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 2024-05-23.
- Submission: K232603
- Applicant / Sponsor: Camdiab , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1356
- Decision date: 2024-05-23
Classification & Regulation
This clearance is catalogued under FDA product code QJI and 21 CFR 862.1356, within the Clinical Chemistry review panel as a Class II device.