FDA applicant

Cal-Tech Diagnostics, Inc.

Monterey Park, CA3 decisions1985–19860 recalls

FDA records 3 decisions for Cal-Tech Diagnostics, Inc. (Monterey Park, CA) from 1985 to 1986: 3 510(k) clearances. All are in product code JHJ (Agglutination Method, Human Chorionic…). 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 Cal-Tech Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cal-Tech Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cal-Tech Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?