510(k) Report

FDA applicant

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

Hennigsdorf, DE1 decision2026–20260 recalls

FDA records 1 decision for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) (Hennigsdorf, DE) in 2026: 1 510(k) clearance. All are in product code SJQ (Unnamed device). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SJQUnnamed device1decision

What has FDA decided for it lately?

  • K260302B·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 QCB·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) · 2026

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