510(k) Report

FDA applicant

The Reagents of the University of Michigan

North Attleboro, MA1 decision2000–20000 recalls

FDA records 1 decision for The Reagents of the University of Michigan (North Attleboro, MA) in 2000: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). 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, radiology panel, where it files most

How often FDA has decided The Reagents of the University of Michigan’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Reagents of the University of Michigan since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Reagents of the University of Michigan 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?

  • KPSSystem, Tomography, Computed, Emission1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K0010263D-MspectThe Reagents of the University of Michigan · 20002cite it

What has FDA decided for it lately?

  • K0010263D-MspectThe Reagents of the University of Michigan · 2000

The one decision as The Reagents of the University of Michigan →

Other applicant names beginning “The”

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

Reagents Applications, Inc. 63