FDA applicant

Roche Image Analysis Systems

Elon College, NC1 decision1995–19950 recalls

FDA records 1 decision for Roche Image Analysis Systems (Elon College, NC) in 1995: 1 510(k) clearance. All are in product code LJM (Antinuclear Antibody (Enzyme-Labeled)…). 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 Image Analysis Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Roche Image Analysis Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Roche Image Analysis Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Image Analysis Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Roche”