510(k) Report

FDA applicant

E K Ind., Inc.

Mchenry, IL50 decisions1984–19840 recalls

FDA records 50 decisions for E K Ind., Inc. (Mchenry, IL) in 1984: 50 510(k) clearances. Most are in product codes HZJ (Stain, Papanicolau) and GGK (Products, Red-Cell Lysing Products). 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 E K Ind., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E K Ind., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like E K Ind., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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