510(k) Report

FDA applicant

Clinical Diagnostics, Inc.

Mchenry, IL8 decisions1977–19980 recalls

FDA records 8 decisions for Clinical Diagnostics, Inc. (Mchenry, IL) from 1977 to 1998: 8 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and LQD (Recorder, Attention Task Performance). 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 Clinical Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clinical Diagnostics, Inc.’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) Report