FDA applicant

Unotech Diagnostics, Inc.

San Leandro, CA3 decisions1997–20030 recalls

FDA records 3 decisions for Unotech Diagnostics, Inc. (San Leandro, CA) from 1997 to 2003: 3 510(k) clearances. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Unotech Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unotech Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Unotech Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?