FDA applicant

Dako Corp.

Carpinteria, CA54 decisions1981–20020 recalls

FDA records 54 decisions for Dako Corp. (Carpinteria, CA) from 1981 to 2002: 54 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and DEH (Lambda, Antigen, Antiserum, Control). Its devices cite 10 predicates, 7 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, immunology panel, where it files most

How often FDA has decided Dako Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dako Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dako Corp.’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 “Dako”

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

Dako North America, Inc. 6 Dako Diagnostics, Ltd. 6 Dako Denmark A/S 4 Dako A/S 2

Dako Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Dako”