510(k) Report

FDA applicant

Flaitron Laboratories, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Flaitron Laboratories, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code KFC (Methylene Blue, Tissue Stain). 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 Flaitron Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flaitron Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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