510(k) Report

FDA applicant

Imi

Rockville, MD1 decision2002–20020 recalls

FDA records 1 decision for Imi (Rockville, MD) in 2002: 1 510(k) clearance. All are in product code LBS (Ldl & Vldl Precipitation, Cholesterol Via…). Its devices cite 1 predicate, 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 chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Imi since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K014018Cholesterol 1, 2, 3Imi · 2002

The one decision as Imi →