FDA applicant

Sero-Immuno Diagnostics, Inc.

Walker, MI3 decisions1984–19850 recalls

FDA records 3 decisions for Sero-Immuno Diagnostics, Inc. (Walker, MI) from 1984 to 1985: 3 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and GNE (Antigen, Latex Agglutination, T. Cruzi). 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 Sero-Immuno Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sero-Immuno Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sero-Immuno Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?