FDA applicant
California Integrated Diagnostics, Inc.
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
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.
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.
See the 510(k) Report