FDA applicant

Breit Laboratories, Inc.

Mchenry, IL5 decisions1983–19850 recalls

FDA records 5 decisions for Breit Laboratories, Inc. (Mchenry, IL) from 1983 to 1985: 5 510(k) clearances. Most are in product codes KHE (Reagent, Occult Blood) and KTL (Anti-Dna Indirect Immunofluorescent Solid Phase). 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 Breit Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Breit Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?