FDA applicant

Roche Professional Diagnostics

Indianapolis, IN2 decisions2010–20150 recalls

FDA records 2 decisions for Roche Professional Diagnostics (Indianapolis, IN) from 2010 to 2015: 2 510(k) clearances. Most are in product codes LOL (Hepatitis A Test (Antibody And Igm Antibody)) and LTK (Test, Epithelial Ovarian Tumor-Associated…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Roche Professional Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Roche Professional Diagnostics by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Roche Professional Diagnostics’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 Molecular System, Inc. 1 Roche Image Analysis Systems 1

Roche Professional Diagnostics

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Roche”