FDA applicant

Roche Tissue Diagnostics, Inc.

Tucson, AZ1 decision2026–20260 recalls

FDA records 1 decision for Roche Tissue Diagnostics, Inc. (Tucson, AZ) in 2026: 1 510(k) clearance. All are in product code PZJ (Lynch Syndrome Test System). 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, immunology panel, where it files most

How often FDA has decided Roche Tissue Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Roche Tissue 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

Other applicant names beginning “Roche”

FDA records each applicant name separately; these may or may not be the same firm.

Roche Diagnostics Corp. 480 Roche Diagnostic Systems, Inc. 296 Roche Molecular Systems, Inc. 70 Roche Medical Electronics, Inc. 16 Roche Diagnostics Operations (Rdo) 14 Roche Diabetes Care, Inc. 13 Roche Analytical Instruments, Inc. 11 Roche Diagnostics Operations 9 Roche 3 Roche Diagnostics/Boehringer Mannheim GmbH 3 Roche Professional Diagnostics 2 Roche Molecular System, Inc. 1

Roche Tissue Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Roche”