510(k) Report

FDA applicant

Clin Tech Diagnostics Corp.

Mchenry, IL5 decisions1980–19820 recalls

FDA records 5 decisions for Clin Tech Diagnostics Corp. (Mchenry, IL) from 1980 to 1982: 5 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and DIF (Drug Mixture Control Materials). 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 toxicology panel, where it files most

How often FDA has decided Clin Tech Diagnostics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clin Tech Diagnostics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clin Tech Diagnostics Corp.’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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