FDA applicant
Alliance International Co., Ltd.
FDA records 2 decisions for Alliance International Co., Ltd. (Hsin-Chu City, TW) from 2009 to 2015: 2 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and NBW (System, Test, Blood Glucose, Over The Counter). 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
How often FDA has decided Alliance International Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Alliance International Co., Ltd.’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 “Alliance”
FDA records each applicant name separately; these may or may not be the same firm.