510(k) Report

FDA applicant

Immuno Assay Corp.

Mchenry, IL10 decisions1981–19840 recalls

FDA records 10 decisions for Immuno Assay Corp. (Mchenry, IL) from 1981 to 1984: 10 510(k) clearances. Most are in product codes CDX (Radioimmunoassay, Total Thyroxine) and CDP (Radioimmunoassay, Total Triiodothyronine). 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 Immuno Assay Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immuno Assay Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Immuno”

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