FDA applicant

Chronimed, Inc.

Eden Prairie, MN5 decisions1997–20011 recall

FDA records 5 decisions for Chronimed, Inc. (Eden Prairie, MN) from 1997 to 2001: 5 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Chronimed, Inc. since 2007.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Chronimed, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?