FDA applicant

Intl. Diagnostic, Inc.

Mchenry, IL6 decisions1978–19840 recalls

FDA records 6 decisions for Intl. Diagnostic, Inc. (Mchenry, IL) from 1978 to 1984: 6 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and DCN (System, Test, C-Reactive Protein). 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 Intl. Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Intl. Diagnostic, Inc.

Which product codes does it file in?

What has FDA decided for it lately?