510(k) Report

FDA applicant

Litton Bionetics

Mchenry, IL15 decisions1978–19840 recalls

FDA records 15 decisions for Litton Bionetics (Mchenry, IL) from 1978 to 1984: 15 510(k) clearances. Most are in product codes GLZ (Antigens, If, Toxoplasma Gondii) and GQH (Antigen, Cf (Including Cf 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Litton Bionetics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Litton”

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