FDA applicant
Dakocytomation California, Inc.
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
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.
Planning a device like Dakocytomation California, 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) ReportOther applicant names beginning “Dakocytomation”
FDA records each applicant name separately; these may or may not be the same firm.