Clearance Summary
BÜHLMANN fCAL® turbo and CALEX® Cap received FDA 510(k) clearance under submission number K232057, sponsored by Bühlmann Laboratories AG. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2024-02-06.
- Submission: K232057
- Applicant / Sponsor: Bühlmann Laboratories AG
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5180
- Decision date: 2024-02-06
Classification & Regulation
This clearance is catalogued under FDA product code NXO and 21 CFR 866.5180, within the Immunology review panel as a Class II device.