510(k) Report

FDA applicant

Bulcher Instruments

Mchenry, IL1 decision1976–19760 recalls

FDA records 1 decision for Bulcher Instruments (Mchenry, IL) in 1976: 1 510(k) clearance. All are in product code JFS (Coulometric, Chloride). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Bulcher Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JFSCoulometric, Chloride1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K760394Reagent, Chloridometer AcidBulcher Instruments · 19761cites it

What has FDA decided for it lately?

  • K760394Reagent, Chloridometer AcidBulcher Instruments · 1976

The one decision as Bulcher Instruments →