510(k) Report

FDA applicant

Interscience Diagnostics, Inc.

Mchenry, IL4 decisions1984–19860 recalls

FDA records 4 decisions for Interscience Diagnostics, Inc. (Mchenry, IL) from 1984 to 1986: 4 510(k) clearances. Most are in product codes GIF (Diluent, Blood Cell) 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Interscience Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Interscience Diagnostics, Inc. 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?

  • GIFDiluent, Blood Cell1decision
  • GGKProducts, Red-Cell Lysing Products1decision
  • KRZCalibrator For Hemoglobin And Hematocrit Measurement1decision
  • PPMGeneral Purpose Reagent1decision

What has FDA decided for it lately?

  • K854166Hematology Calibrator ControlInterscience Diagnostics, Inc. · 1986
  • K842068Idi Isotonic DiluentInterscience Diagnostics, Inc. · 1984
  • K842069Idl-Lysing ReagentInterscience Diagnostics, Inc. · 1984
  • K842070Idd DetergentInterscience Diagnostics, Inc. · 1984

All 4 as Interscience Diagnostics, Inc. →

Other applicant names beginning “Interscience”

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

Interscience, Inc. 4