FDA applicant

Bayer Healthcare, Diagnostics Division

Tarrytown, NY3 decisions2004–20051 recall

FDA records 3 decisions for Bayer Healthcare, Diagnostics Division (Tarrytown, NY) from 2004 to 2005: 2 510(k) clearances and 1 original PMA approval. Most are in product codes JIT (Calibrator, Secondary) and CGA (Glucose Oxidase, Glucose). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Healthcare, Diagnostics Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bayer Healthcare, Diagnostics Division since 2007.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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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 Corp., Agfa Div. 3 Bayer Group Diagnostics 2 Bayer U.S., LLC 1 Bayer Pharma AG 1

Bayer Healthcare, Diagnostics Division

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?

What has been recalled?

Other applicant names beginning “Bayer”