510(k) Report

FDA applicant

Case Instruments

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Case Instruments (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code HYF (Giemsa 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 Case Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Case Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Case”

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