FDA applicant

Gds Technology, LLC

Elkhart, IN8 decisions1988–20020 recalls

FDA records 8 decisions for Gds Technology, LLC (Elkhart, IN) from 1988 to 2002: 8 510(k) clearances. Most are in product codes KHG (Whole Blood Hemoglobin Determination) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gds Technology”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Gds Technology, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gds Technology, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?