510(k) Report

FDA applicant

Apple Diagnostic Products

Mchenry, IL7 decisions1984–19850 recalls

FDA records 7 decisions for Apple Diagnostic Products (Mchenry, IL) from 1984 to 1985: 7 510(k) clearances. Most are in product codes DHN (Antinuclear Antibody, Indirect…) and LJC (Enzyme Linked Immunoabsorbent Assay…). 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, immunology panel, where it files most

How often FDA has decided Apple Diagnostic Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apple Diagnostic Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apple Diagnostic Products’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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Other applicant names beginning “Apple”

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