Clearance Summary
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC received FDA 510(k) clearance under submission number K222251, sponsored by B.R.A.H.M.S GmbH, Part of Thermo Fisher. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2023-09-18.
- Submission: K222251
- Applicant / Sponsor: B.R.A.H.M.S GmbH, Part of Thermo Fisher
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2023-09-18
Classification & Regulation
This clearance is catalogued under FDA product code QXS and 21 CFR 866.6010, within the Immunology review panel as a Class II device.