FDA applicant
Apple Diagnostic Products
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Apple”
FDA records each applicant name separately; these may or may not be the same firm.