510(k) Report

FDA applicant

Radioimmunoassay, Inc.

Mchenry, IL9 decisions1978–19800 recalls

FDA records 9 decisions for Radioimmunoassay, Inc. (Mchenry, IL) from 1978 to 1980: 9 510(k) clearances. Most are in product codes CDX (Radioimmunoassay, Total Thyroxine) and CDZ (Radioimmunoassay, Testosterones And…). 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 Radioimmunoassay, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Radioimmunoassay, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Radioimmunoassay, 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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