FDA applicant

Lipogen, Inc.

Knoxville, TN15 decisions1987–19900 recalls

FDA records 15 decisions for Lipogen, Inc. (Knoxville, TN) from 1987 to 1990: 15 510(k) clearances. Most are in product codes LJM (Antinuclear Antibody (Enzyme-Labeled)…) and LKP (Anti-Sm Antibody, Antigen And Control). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Lipogen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Lipogen, Inc.

Which product codes does it file in?

What has FDA decided for it lately?