FDA applicant

Bartels, Inc.

Issaquah, WA2 decisions1995–19960 recalls

FDA records 2 decisions for Bartels, Inc. (Issaquah, WA) from 1995 to 1996: 2 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and JZT (Fluorometer). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Bartels, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bartels, 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 “Bartels”

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

Bartels Immunodiagnostic Supplies, Inc. 35 Bartels & Stout, Inc. 3 Bartels Prognostics, Inc. 1

Bartels, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bartels”