510(k) Report

FDA applicant

Dia-Screen Corp.

Edina, MN1 decision1997–19970 recalls

FDA records 1 decision for Dia-Screen Corp. (Edina, MN) in 1997: 1 510(k) clearance. All are in product code LJX (Test, Urine Leukocyte). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Dia-Screen Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dia-Screen Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dia-Screen Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dia-Screen Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LJXTest, Urine Leukocyte1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K971976Diascreen Reagent StripsDia-Screen Corp. · 19972cite it

What has FDA decided for it lately?

  • K971976Diascreen Reagent StripsDia-Screen Corp. · 1997

The one decision as Dia-Screen Corp. →