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— 510(k) K260302

Name: FDA 510(k) clearance K260302
Creator: U.S. Food and Drug Administration
Published: 2026-10-23

Substantially Equivalent

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

FDA 510(k) clearance K260302 for 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, Substantially Equivalent on 2026-10-23. Applicant: B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific).

Clearance details

Applicant: B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
Product code: Product code SJQ
Advisory panel: Microbiology
Date received: 2026-01-30
Decision date: 2026-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hennigsdorf, DE

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