510(k) Report

FDA applicant

Reaads Medical Products, Inc.

Westminister, CO4 decisions1995–19971 recall

FDA records 4 decisions for Reaads Medical Products, Inc. (Westminister, CO) from 1995 to 1997: 4 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and MID (System, Test, Anticardiolipin Immunological). 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, hematology panel, where it files most

How often FDA has decided Reaads Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Reaads Medical Products, Inc. since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Reaads Medical Products, 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?

  • GGPTest, Qualitative And Quantitative Factor Deficiency3decisions
  • MIDSystem, Test, Anticardiolipin Immunological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972482Reaads Protein S Antigen Test KitReaads Medical Products, Inc. · 19971cites it

What has FDA decided for it lately?

  • K972342Reaads Protein C Antigen Test KitReaads Medical Products, Inc. · 1997
  • K972482Reaads Protein S Antigen Test KitReaads Medical Products, Inc. · 19971 recall
  • K972005Reaads Von Willebrand Factor Antigen Test KitReaads Medical Products, Inc. · 1997
  • K952287Reaads Anti-Phosphatidylserine Quantitative Test KitReaads Medical Products, Inc. · 1995

All 4 as Reaads Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K972482"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free…Apr 4, 2017Class II