FDA applicant

Diatron U.S., Inc.

Lenexa, KS3 decisions2012–20162 recalls

FDA records 3 decisions for Diatron U.S., Inc. (Lenexa, KS) from 2012 to 2016: 3 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and CFR (Hexokinase, Glucose). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are 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 Diatron U.S., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2016

2012high 2 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Diatron U.S., Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Diatron”

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

Diatron Group 2 Diatron Corp. 1

Diatron U.S., Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Diatron”