Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013223546

FEI Number

3013223546

Entity Name

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

City/State/Country

Hangzhou, Zhuji Zhejiang, CN

Establishment 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 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VivaChek Biotech (Hangzhou) Co., Ltd (Owner Number: 10055002)

Owner / Operator Contact Address

No.17 Wuzhou Road, Donghu Street, Linping District,, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233062

PMA Number

N/A

All Registered Proprietary Names

VivaGuard Ino Sound Simple Blood Glucose Monitoring System VivaGuard Ino BLOOD GLUCOSE TEST STRIPS VivaGuard Multi-Drug Urine Test Cup VivaGuard Multi-Drug Urine Test Cup Rx VivaDiag Marijuana (THC) Rapid Test VivaDiag Fentanyl Test Kit (FIA) VivaDiag POCT Multifunction Meter VivaGuard Fad Blood Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-02-19
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2022-12-04
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2022-12-04
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2022-12-04
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2022-12-04
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2022-12-04
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2022-12-04
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2022-12-04
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2022-12-04
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2022-12-04
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2022-12-04
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2022-12-04
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-06-02
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2026-06-02
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-06-02
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-06-02
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-06-02
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-06-02
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-06-02
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-06-02
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-06-02
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-06-02
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-06-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-10-04
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2023-11-10
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2020-06-27
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2025-03-06
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-03-06
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-05-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-05-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-05-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-04-16
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-12-01
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-12-01
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-12-01
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-12-01
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-12-01
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-12-01
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-12-01
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-12-01
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-12-01
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-12-01
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-12-01
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2024-03-18
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2023-11-10
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2023-11-10
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2023-11-10
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2023-11-10
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2023-11-10
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2023-11-10
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2023-11-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2023-11-10
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2023-11-10
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2023-11-10
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2023-11-10

Official Correspondent

Mark Qian

US Agent Details

Ashish Parikh Email: ashish.parikh@vivachekdx.com Phone: (224) 3607669

Related Public Records

Same Entity

VivaChek Biotech (Hangzhou) Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25
K163220	Siemens Healthcare Diagnostics, Inc.	Atellica CH Phencyclidine (Pcp)	2017-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013223546. Last updated year: 2026. Please use registration number 3013223546 when referencing this establishment in official correspondence.