510(k) Report

FDA applicant

Technia Diagnostics, Ltd.

Mchenry, IL9 decisions1979–19860 recalls

FDA records 9 decisions for Technia Diagnostics, Ltd. (Mchenry, IL) from 1979 to 1986: 9 510(k) clearances. Most are in product codes KTL (Anti-Dna Indirect Immunofluorescent Solid Phase) and CDD (Radioassay, Vitamin B12). 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 Technia Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Technia Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Technia Diagnostics, Ltd.’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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