Vivachek Biotech (Hangzhou) Co., Ltd
Hangzhou, Zhuji Zhejiang, CN
VIVACHEK BIOTECH (HANGZHOU) CO., LTD appears in FDA device records in Hangzhou, Zhuji Zhejiang, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Vivachek Biotech (Hangzhou) Co., Ltd between 2020 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | NFT | Substantially Equivalent | |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | NFT | Substantially Equivalent | |
| K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader | NGL | Substantially Equivalent | |
| K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | DJG | Substantially Equivalent | |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | Substantially Equivalent | |
| 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 | |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | Substantially Equivalent | |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | JIN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013223546 | 3013223546 | VIVACHEK BIOTECH (HANGZHOU) CO., LTD | No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100, Hangzhou, Zhuji Zhejiang 311100 CN | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FENDevice, Cystometric, Hydraulic
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- KHOFluorometer, For Clinical Use
- CGAGlucose Oxidase, Glucose
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
- NFTTest, Amphetamine, Over The Counter
- PTHTest, Barbiturate, Over The Counter
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain