FDA applicant

Bayer Group Diagnostics

Elkhart, IN2 decisions2002–20020 recalls

FDA records 2 decisions for Bayer Group Diagnostics (Elkhart, IN) in 2002: 2 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). 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 Bayer Group Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bayer Group Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bayer Group Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bayer Group Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Bayer”

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

Bayer Corp. 96 Bayer Healthcare, LLC 58 Bayer Diagnostics Corp. 32 Bayer Medical Care, Inc. 11 Bayer Healthcare, Diagnostics Division 3 Bayer Corp., Agfa Div. 3 Bayer U.S., LLC 1 Bayer Pharma AG 1

Bayer Group Diagnostics

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 “Bayer”