510(k) Report

FDA applicant

Livonia Diagnostics, Inc.

Livonia, MI16 decisions1984–19850 recalls

FDA records 16 decisions for Livonia Diagnostics, Inc. (Livonia, MI) from 1984 to 1985: 16 510(k) clearances. Most are in product codes CIC (Cresolphthalein Complexone, Calcium) and CEO (Phosphomolybdate (Colorimetric), Inorganic…). 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 Livonia Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Livonia Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Livonia 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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