510(k) Report

FDA applicant

Institut National Des Radioelements

Walker, MI2 decisions1979–19840 recalls

FDA records 2 decisions for Institut National Des Radioelements (Walker, MI) from 1979 to 1984: 2 510(k) clearances. Most are in product codes JKD (Radioimmunoassay, C-Peptides Of Proinsulin) and CEW (Radioimmunoassay, Parathyroid Hormone). 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 Institut National Des Radioelements’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Institut National Des Radioelements since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JKDRadioimmunoassay, C-Peptides Of Proinsulin1decision
  • CEWRadioimmunoassay, Parathyroid Hormone1decision

What has FDA decided for it lately?

  • K842267C-Pep-Ria-100Institut National Des Radioelements · 1984
  • K791128PTH Ria 200Institut National Des Radioelements · 1979

All 2 as Institut National Des Radioelements →

Other applicant names beginning “Institut”

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

Institut Straumann AG 92Institut Georges Lopez 3Institut Biochimique SA (Ibsa) 1Institut Geroges Lopez 1