510(k) Report

FDA applicant

California Integrated Diagnostics, Inc.

Berkeley, CA4 decisions1987–19910 recalls

FDA records 4 decisions for California Integrated Diagnostics, Inc. (Berkeley, CA) from 1987 to 1991: 4 510(k) clearances. Most are in product codes JWZ (Kit, Screening, Trichomonas) and GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). 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 California Integrated Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for California Integrated Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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