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
FDA 510(k) clearance K222251 · decided 2023-09-18
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2022-07-27
- Decision date
- 2023-09-18
- Days to decision
- 418 days
- Clearance type
- Traditional
- Product code
- QXS
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Hennigsdorf, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.