510(k) clearance

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC

FDA 510(k) source

510(k) number

K260302

Applicant

B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)

Decision date

Oct 23, 2026

Date received

Jan 30, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SJQ

Advisory committee

Microbiology

Statement or summary

Summary

Third party

N

Location

Hennigsdorf, DE