Vivachek Biotech (Hangzhou) Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Vivachek Biotech (Hangzhou) Co., Ltd.” (first 2020, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. Since 2017 the median was 76 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 228 |
| 2021 | 0 | — |
| 2022 | 1 | 65 |
| 2023 | 3 | 59 |
| 2024 | 3 | 150 |
| 2025 | 1 | 30 |
| 2026 | 1 | 35 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vivachek Biotech (Hangzhou) Co., Ltd. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 4 | 4 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 1 |
| NFW | Test, Cannabinoid, Over The Counter | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
Review panels
Most recent Vivachek Biotech (Hangzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | NFT | 2026-05-22 | 35 |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | NFT | 2025-09-12 | 30 |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | NGL | 2024-10-04 | 99 |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | NBW | 2024-08-16 | 760 |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | DJG | 2024-06-14 | 150 |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | NBW | 2023-12-22 | 88 |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | 2023-11-02 | 37 |
| K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 | NFW | 2023-08-31 | 59 |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | 2022-11-10 | 65 |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | JIN | 2020-06-05 | 228 |
Recalls
openFDA lists no recalls under a recalling firm named Vivachek Biotech (Hangzhou) Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vivachek Laboratories, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vivachek Biotech (Hangzhou) Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Vivachek Biotech (Hangzhou) Co., Ltd.” (first 2020, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vivachek Biotech (Hangzhou) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vivachek Biotech (Hangzhou) Co., Ltd. is 76 days. Since 2017: 76 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vivachek Biotech (Hangzhou) Co., Ltd.?
The most frequent FDA product codes under this applicant name are NFT (Test, Amphetamine, Over The Counter, 4); NBW (System, Test, Blood Glucose, Over The Counter, 2); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 10 Vivachek Biotech (Hangzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFT, Vivachek Biotech (Hangzhou) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.