FDA applicant

Roche Analytical Instruments, Inc.

Mchenry, IL11 decisions1980–19800 recalls

FDA records 11 decisions for Roche Analytical Instruments, Inc. (Mchenry, IL) in 1980: 11 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Roche Analytical Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Roche Analytical Instruments, Inc. 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 Diagnostics Operations 9 Roche 3 Roche Diagnostics/Boehringer Mannheim GmbH 3 Roche Professional Diagnostics 2 Roche Molecular System, Inc. 1 Roche Image Analysis Systems 1

Roche Analytical Instruments, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Roche”