FDA applicant

Immucor Gti Diagnostics, Inc.

Waukesha, WI2 decisions2020–20200 recalls

FDA records 2 decisions for Immucor Gti Diagnostics, Inc. (Waukesha, WI) in 2020: 2 510(k) clearances. All are in product code LCO (Platelet Factor 4 Radioimmunoassay). Its devices cite 2 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 Immucor Gti Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Immucor Gti Diagnostics, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Immucor Gti Diagnostics, 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 “Immucor”

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

Immucor, Inc. 3

Immucor Gti Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Immucor”