FDA applicant

U. S. Diagnostics, Inc.

San Luis Obispo, CA22 decisions1986–20110 recalls

FDA records 22 decisions for U. S. Diagnostics, Inc. (San Luis Obispo, CA) from 1986 to 2011: 22 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 10 predicates, 1 of them its own earlier devices. 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 U. S. Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like U. S. Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

U. S. Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?