FDA applicant
Vivachek Biotech (Hangzhou) Co., Ltd.
FDA records 11 decisions for Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN) from 2020 to 2026: 11 510(k) clearances. Most are in product codes NFT (Test, Amphetamine, Over The Counter) and NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 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 Vivachek Biotech (Hangzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Vivachek Biotech (Hangzhou) 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 “Vivachek”
FDA records each applicant name separately; these may or may not be the same firm.