510(k) Report

FDA applicant

Bartels Immunodiagnostic Supplies, Inc.

Mchenry, IL35 decisions1981–19860 recalls

FDA records 35 decisions for Bartels Immunodiagnostic Supplies, Inc. (Mchenry, IL) from 1981 to 1986: 35 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and KIT (Media And Components, Synthetic Cell And…). 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 Immunodiagnostic Supplies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bartels Immunodiagnostic Supplies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bartels Immunodiagnostic Supplies, Inc.’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 “Bartels”

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