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— 510(k) K222251
Substantially EquivalentB.R.A.H.M.S GmbH, Part of Thermo Fisher
FDA 510(k) clearance K222251 for 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, Substantially Equivalent on 2023-09-18. Applicant: B.R.A.H.M.S GmbH, Part of Thermo Fisher. Device class: 2.
Clearance details
- Applicant
- B.R.A.H.M.S GmbH, Part of Thermo Fisher
- Product code
- Code QXS
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hennigsdorf, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.