510(k) Report

FDA applicant

Diagnostic Technology, Inc.

Mchenry, IL28 decisions1979–19910 recalls

FDA records 28 decisions for Diagnostic Technology, Inc. (Mchenry, IL) from 1979 to 1991: 28 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and JHJ (Agglutination Method, Human Chorionic…). 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 Diagnostic Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostic Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Diagnostic”

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