510(k) Report

FDA applicant

Precision Technology, Inc.

Mchenry, IL3 decisions1984–19841 recall

FDA records 3 decisions for Precision Technology, Inc. (Mchenry, IL) in 1984: 3 510(k) clearances. Most are in product codes JPH (Test, Erythrocyte Sedimentation Rate) and JJE (Analyzer, Chemistry (Photometric, Discrete)…). 1 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 Precision Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Technology, Inc. since 2007.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Precision Technology, 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?

  • JPHTest, Erythrocyte Sedimentation Rate1decision
  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1decision
  • JQPCalculator/Data Processing Module, For Clinical Use1decision

What has FDA decided for it lately?

  • K840501Acculab Supplies Chemical AnalyzersPrecision Technology, Inc. · 1984
  • K840502Cats-Clinical Lab Computer Software-Precision Technology, Inc. · 1984
  • K840500SediplastPrecision Technology, Inc. · 19841 recall

All 3 as Precision Technology, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K840500SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;Aug 25, 2026Class II