FDA applicant

Worthington Diagnostic Systems

Mchenry, IL19 decisions1979–19840 recalls

FDA records 19 decisions for Worthington Diagnostic Systems (Mchenry, IL) from 1979 to 1984: 19 510(k) clearances. Most are in product codes JHS (Differential Rate Kinetic Method, Cpk Or…) and KNK (Acid, Uric, Uricase (Colorimetric)). 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 Worthington Diagnostic Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Worthington Diagnostic Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Worthington Diagnostic Systems’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

Other applicant names beginning “Worthington”

FDA records each applicant name separately; these may or may not be the same firm.

Worthington Biochemical Corp. 13

Worthington Diagnostic Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Worthington”