510(k) Report

FDA applicant

Jrga Diagnostics

San Juan Capistrano, CA1 decision1992–19920 recalls

FDA records 1 decision for Jrga Diagnostics (San Juan Capistrano, CA) in 1992: 1 510(k) clearance. All are in product code JXC (Kit, Screening, Yeast). 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 Jrga Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jrga Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jrga Diagnostics 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?

  • JXCKit, Screening, Yeast1decision

What has FDA decided for it lately?

  • K913426Albicans SureJrga Diagnostics · 1992

The one decision as Jrga Diagnostics →