K222251
- 510(k) number
- K222251
- Device name
- 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
- Applicant
- B.R.A.H.M.S GmbH, Part of Thermo Fisher DE
- Product code
- QXS — Chromogranin A
- Decision date
- 2023-09-18
- Date received
- 2022-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K222251.pdf
Official FDA record: K222251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.