510(k) Report

FDA applicant

Dakocytomation California, Inc.

Carpinteria, CA2 decisions2005–20060 recalls

FDA records 2 decisions for Dakocytomation California, Inc. (Carpinteria, CA) from 2005 to 2006: 2 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and MXZ (Immunohistochemistry Assay, Antibody…). Its devices cite 8 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 Dakocytomation California, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dakocytomation California, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Dakocytomation”

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