FDA applicant

Gds Diagnostics

Elkhart, IN4 decisions1989–19935 recalls

FDA records 4 decisions for Gds Diagnostics (Elkhart, IN) from 1989 to 1993: 4 510(k) clearances. Most are in product codes LCY (U.V. Spectrometry, Theophylline) and LDP (Colorimetry, Acetaminophen). 5 recalls are linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Gds Diagnostics since 2007.

Recalls per year

5in 2021

2007high 5 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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Gds Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?