Medical Device Manufacturer · CN , Hangzhou

Vivachek Biotech (Hangzhou) Co., Ltd.

9 submissions · 9 cleared · Since 2020
9
Total
9
Cleared
0
Denied

Vivachek Biotech (Hangzhou) Co., Ltd. — FDA 510(k) Submissions

Vivachek Biotech (Hangzhou) Co., Ltd. has submitted 9 FDA 510(k) premarket notifications since 2020, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Amphetamine, Over The Counter, System, Test, Blood Glucose, Over The Counter, Enzyme Immunoassay, Opiates, Test, Opiates, Over The Counter, Nitroprusside, Ketones (urinary, Non-quant.) . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
K252554 · NFT Test, Amphetamine, Over... · Toxicology
Sep 2025 30d
BioSieve? Fentanyl FIA Home Test Kit; BioSieve? Fentanyl FIA Pro Test Kit; BioSieve? Toxismart Reader
K241869 · NGL Test, Opiates, Over The... · Toxicology
Oct 2024 99d
VivaChek? Fad Blood Glucose Monitoring System, VivaChek? Fad Smart Blood Glucose Monitoring System, VivaChek? Fad Sync Blood Glucose Monitoring System
K222126 · NBW System, Test, Blood... · Chemistry
Aug 2024 760d
BioSieve? Fentanyl FIA Test Kit; BioSieve? ToxiSmart FIA Reader
K240124 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2024 150d
VivaChek Link Plus Blood Glucose Monitoring System
K233058 · NBW System, Test, Blood... · Chemistry
Dec 2023 88d
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
K233062 · NFT Test, Amphetamine, Over... · Toxicology
Nov 2023 37d
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
K231978 · NFW Test, Cannabinoid, Over... · Toxicology
Aug 2023 59d
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667 · NFT Test, Amphetamine, Over... · Toxicology
Nov 2022 65d
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · JIN Nitroprusside, Ketones... · Chemistry
Jun 2020 228d
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