510(k) Report

FDA applicant

Brahms Diagnostica, LLC

Norcross, GA6 decisions1999–20040 recalls

FDA records 6 decisions for Brahms Diagnostica, LLC (Norcross, GA) from 1999 to 2004: 6 510(k) clearances. Most are in product codes JZO (System, Test, Thyroid Autoantibody) and MSW (System, Test, Thyroglobulin). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, immunology panel, where it files most

How often FDA has decided Brahms Diagnostica, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brahms Diagnostica, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Brahms Diagnostica, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Brahms Diagnostica, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JZOSystem, Test, Thyroid Autoantibody5decisions
  • MSWSystem, Test, Thyroglobulin1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K992790Brahms Diagnostica Dynotest Anti-TGBrahms Diagnostica, LLC · 19991cites it
  • K033454Brahms Diagnostica Lumitest Trak HumanBrahms Diagnostica, LLC · 20041cites it

What has FDA decided for it lately?

  • K033454Brahms Diagnostica Lumitest Trak HumanBrahms Diagnostica, LLC · 2004
  • K021057Brahms Diagnostica Dynotest TG-PlusBrahms Diagnostica, LLC · 2002
  • K000286Brahms Diagnostica Lumitest Anti-TGBrahms Diagnostica, LLC · 2000
  • K000287Brahms Diagnostica Lumitest Anti-TpoBrahms Diagnostica, LLC · 2000
  • K992790Brahms Diagnostica Dynotest Anti-TGBrahms Diagnostica, LLC · 1999
  • K992791Brahms Diagnostica Dynotest Anti-TpoBrahms Diagnostica, LLC · 1999

All 6 as Brahms Diagnostica, LLC →

Other applicant names beginning “Brahms”

FDA records each applicant name separately; these may or may not be the same firm.

Brahms GmbH 2Brahms Aktiengesellschaft 2Brahms GmbH, Part of Thermo Fisher Scientific 1B.R.A.H.M.S GmbH, Part of Thermo Fisher 1