510(k) Report

FDA applicant

Central Labs. Assoc. MD Pathologists

Mchenry, IL3 decisions1976–19770 recalls

FDA records 3 decisions for Central Labs. Assoc. MD Pathologists (Mchenry, IL) from 1976 to 1977: 3 510(k) clearances. Most are in product codes JCE (Solution, Isotonic) and GGK (Products, Red-Cell Lysing Products). 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, pathology panel, where it files most

How often FDA has decided Central Labs. Assoc. MD Pathologists’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Central Labs. Assoc. MD Pathologists since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Central Labs. Assoc. MD Pathologists 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?

  • JCESolution, Isotonic1decision
  • GGKProducts, Red-Cell Lysing Products1decision
  • IGGFormaldehyde (Formalin, Formol)1decision

What has FDA decided for it lately?

  • K771201Formalin Buffer ConcentrateCentral Labs. Assoc. MD Pathologists · 1977
  • K761183Lysing Agent AFCentral Labs. Assoc. MD Pathologists · 1977
  • K761182Isotonic Diluent AFCentral Labs. Assoc. MD Pathologists · 1976

All 3 as Central Labs. Assoc. MD Pathologists →