510(k) Report

FDA applicant

Iso-Data, Inc.

Mchenry, IL7 decisions1978–19870 recalls

FDA records 7 decisions for Iso-Data, Inc. (Mchenry, IL) from 1978 to 1987: 7 510(k) clearances. Most are in product codes JJJ (Counter (Beta, Gamma) For Clinical Use) and JQP (Calculator/Data Processing Module, For…). 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, clinical chemistry panel, where it files most

How often FDA has decided Iso-Data, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iso-Data, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iso-Data, 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?

  • JJJCounter (Beta, Gamma) For Clinical Use3decisions
  • JQPCalculator/Data Processing Module, For Clinical Use2decisions
  • JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use1decision

What has FDA decided for it lately?

  • K872430Iso-Data 500 Series Gamma CounterIso-Data, Inc. · 1987
  • K872429Iso-Data 100 Series Gamma CounterIso-Data, Inc. · 1987
  • K843434Iso-Data Centrifuges 1-a, 101, 2D, Etc.Iso-Data, Inc. · 1984
  • K843365Iso-Data Immunoassay Network SystemIso-Data, Inc. · 1984
  • K810631DPM CalculatorIso-Data, Inc. · 1981
  • K780813Idi GDR Data Reduction SystemIso-Data, Inc. · 1978
  • K780790Idi 200 Gamma CounterIso-Data, Inc. · 1978

All 7 as Iso-Data, Inc. →