510(k) Report

FDA applicant

Siemens Helathcare Diagnostics, Inc.

West Sacramento, CA2 decisions2013–20130 recalls

FDA records 2 decisions for Siemens Helathcare Diagnostics, Inc. (West Sacramento, CA) in 2013: 2 510(k) clearances. Most are in product codes LTT (Panels, Test, Susceptibility, Antimicrobial) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 4 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, microbiology panel, where it files most

How often FDA has decided Siemens Helathcare Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Siemens Helathcare Diagnostics, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LTTPanels, Test, Susceptibility, Antimicrobial1decision
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131275Microscan Dried Gram-Postive Mic/Combo PanelsSiemens Helathcare Diagnostics, Inc. · 2013
  • K132391Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB Calibration…Siemens Helathcare Diagnostics, Inc. · 2013

All 2 as Siemens Helathcare Diagnostics, Inc. →