510(k) Report

FDA applicant

Bioassay Systems Research Corp.

Mchenry, IL3 decisions1977–19850 recalls

FDA records 3 decisions for Bioassay Systems Research Corp. (Mchenry, IL) from 1977 to 1985: 3 510(k) clearances. Most are in product codes KPB (Media And Components, Mycoplasma Detection) and KIR (Cells, Animal And Human, Cultured). 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 Bioassay Systems Research Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioassay Systems Research Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KPBMedia And Components, Mycoplasma Detection1decision
  • KIRCells, Animal And Human, Cultured1decision
  • KITMedia And Components, Synthetic Cell And Tissue Culture1decision

What has FDA decided for it lately?

  • K850990HFF GencellsBioassay Systems Research Corp. · 1985
  • K780869Cell Culture LinesBioassay Systems Research Corp. · 1978
  • K771867Mycoplasma Detection KitBioassay Systems Research Corp. · 1977

All 3 as Bioassay Systems Research Corp. →