FDA applicant
Bartels Immunodiagnostic Supplies, Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Bartels”
FDA records each applicant name separately; these may or may not be the same firm.