FDA applicant
Apex BioTechnology Corp.
FDA records 35 decisions for Apex BioTechnology Corp. (Hsinchu, TW) from 2001 to 2025: 35 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Since 2016 its 510(k)s took a median of 228 days from receipt to decision, against 410 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 24 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Apex BioTechnology Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Apex BioTechnology 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) ReportOther applicant names beginning “Apex”
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