510(k) Report

FDA applicant

Avanti Polar Lipids, Inc.

Alabaster, AL1 decision1999–19990 recalls

FDA records 1 decision for Avanti Polar Lipids, Inc. (Alabaster, AL) in 1999: 1 510(k) clearance. All are in product code GMQ (Antigens, Nontreponemal, All). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Avanti Polar Lipids, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avanti Polar Lipids, Inc.’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 “Avanti”

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