510(k) Report

FDA applicant

Cdc Technologies, Inc.

Washington, DC2 decisions1998–19980 recalls

FDA records 2 decisions for Cdc Technologies, Inc. (Washington, DC) in 1998: 2 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Its devices cite 2 predicates, 1 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 Cdc Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cdc Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cdc Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cdc Technologies, 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

Which product codes does it file in?

  • GKZCounter, Differential Cell2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981568Mascot MD Hematology Analyzer, Model MD 800Cdc Technologies, Inc. · 19981cites it

What has FDA decided for it lately?

  • K983562Mascot MD Hematology Analyzer/ Model MD 700Cdc Technologies, Inc. · 1998
  • K981568Mascot MD Hematology Analyzer, Model MD 800Cdc Technologies, Inc. · 1998

All 2 as Cdc Technologies, Inc. →