FDA applicant

Dako North America, Inc.

Carpinteria, CA6 decisions2005–20160 recalls

FDA records 6 decisions for Dako North America, Inc. (Carpinteria, CA) from 2005 to 2016: 4 510(k) clearances and 2 original PMA approvals. Most are in product codes MXZ (Immunohistochemistry Assay, Antibody…) and MYA (Immunohistochemistry Antibody Assay, Estrogen…). Its devices cite 5 predicates, 2 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 Dako North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dako North America, 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 “Dako”

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

Dako Corp. 54 Dako Diagnostics, Ltd. 6 Dako Denmark A/S 4 Dako A/S 2

Dako North America, Inc.

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”