FDA applicant

Baker Diagnostics

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Baker Diagnostics (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code 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 Baker Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baker Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Baker”

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

Baker Instructions Corp. 10 Baker-Sundt Research, Inc. 1 Baker & Hostetler 1

Baker Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Baker”