510(k) K222251

Device

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

510(k) number

K222251

Product code

QXS

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-18

Date received

2022-07-27

Regulation

866.6010

Classification name

Chromogranin A

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No