FDA applicant
United Diagnostics, Inc.
FDA records 12 decisions for United Diagnostics, Inc. (Mchenry, IL) from 1979 to 1989: 12 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJS (Controls For Blood-Gases, (Assayed And…). 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 United Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for United Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like United Diagnostics, 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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