Data / Medical devices / China / Vivachek Biotech (hangzhou) Co., Ltd
Vivachek Biotech (hangzhou) Co., Ltd: FDA-registered device maker in Hangzhou, Zhuji Zhejiang, China, 12 510(k) clearances
Vivachek Biotech (hangzhou) Co., Ltd is registered with the FDA (registration 3013223546) in Hangzhou, Zhuji Zhejiang, China. It lists 21 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013223546
- Address
- No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 Building 2 and Building 3, No.17 Jianxing Road, Taozhu Street, Zhuji, 311800, Hangzhou, Zhuji Zhejiang, China, 311100
- Owner or operator
- VivaChek Biotech (Hangzhou) Co., Ltd (10055002)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 23, 2017
- Registered through
- 2026
- Brand names listed
- VivaDiag Fentanyl Test Kit (FIA), VivaDiag Marijuana (THC) Rapid Test, VivaDiag POCT Analyzer (Models: VIM1000; VIM2000; VIM3000), VivaDiag POCT Multifunction Meter, VivaGuard Fad Blood Glucose Monitoring System, VivaGuard Ino BLOOD GLUCOSE TEST STRIPS, VivaGuard Ino Sound Simple Blood Glucose Monitoring System, VivaGuard Multi-Drug Urine Test Cup and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| September 12, 2025 | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | NGL | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| August 16, 2024 | K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| June 14, 2024 | K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | DJG | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| November 2, 2023 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| August 31, 2023 | 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 | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| November 10, 2022 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| June 5, 2020 | K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | JIN | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| December 19, 2018 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
| April 21, 2017 | K160179 | VivaChek Ino Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
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Updated May 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.