FDA applicant

Si Sero-Immuno Diagnostics, Inc.

Tucker, GA2 decisions1985–19850 recalls

FDA records 2 decisions for Si Sero-Immuno Diagnostics, Inc. (Tucker, GA) in 1985: 2 510(k) clearances. All are in product code GMM (Antigens, Iha, Toxoplasma Gondii). 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, microbiology panel, where it files most

How often FDA has decided Si Sero-Immuno Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Si Sero-Immuno Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?