510(k) Report

FDA applicant

Labnet Intl., Inc.

Woodbridge, NJ1 decision1992–19920 recalls

FDA records 1 decision for Labnet Intl., Inc. (Woodbridge, NJ) in 1992: 1 510(k) clearance. All are in product code GKG (Centrifuge, Hematocrit). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Labnet Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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