FDA applicant

Medtest DX

Lincoln Park, MI2 decisions2020–20200 recalls

FDA records 2 decisions for Medtest DX (Lincoln Park, MI) in 2020: 2 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). Its devices cite 2 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, clinical toxicology panel, where it files most

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

FDA decisions per year

2in 2020

2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Medtest DX by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtest DX’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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Other applicant names beginning “Medtest”

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

Medtest Systems, Inc. 1

Medtest DX

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Medtest”