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Hangzhou Tongzhou Biotechnology Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 6 510(k) clearances

Name: Hangzhou Tongzhou Biotechnology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hangzhou Tongzhou Biotechnology Co., Ltd is registered with the FDA (registration 3021986677) in Hangzhou Zhejiang, China. It lists 38 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 4, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3021986677
Address: No. 1 Ninghong Road, Donghu Street, Linping District, Hangzhou Zhejiang, China, 311199
Owner or operator: Hangzhou Tongzhou Biotechnology Co., Ltd (10084418)
Roles: Manufacturer, Repackager or relabeler
First device listed: February 18, 2022
Registered through: 2027
Brand names listed: AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, CODEINE Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT, HINDERING Fentanyl Rapid Test, HINDERING Fentanyl Urine Rapid Test Cassette, HINDERING Multi-Drug Rapid Test Cup and more

Devices it lists

Device	Product code	Class	Role	Source
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	2	Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, Exempt	PUX	2	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Repackager or relabeler	accessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, Exempt	PUY	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Repackager or relabeler	accessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, Exempt	PUZ	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, Exempt	PVJ	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	PVA	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Repackager or relabeler	accessdata.fda.gov
Test, Codeine, Employment And Insurance Testing, Exempt	PVB	2	Manufacturer	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, Exempt	PVE	2	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Repackager or relabeler	accessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, Exempt	PVD	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Repackager or relabeler	accessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, Exempt	PVF	2	Manufacturer	accessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, Exempt	PVG	2	Manufacturer	accessdata.fda.gov
Test, Morphine, Over The Counter	NGI	2	Repackager or relabeler	accessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, Exempt	PVH	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Repackager or relabeler	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Repackager or relabeler	accessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, Exempt	PVI	2	Manufacturer	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	PVK	2	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Morphine	DNK	2	Repackager or relabeler	accessdata.fda.gov

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
April 4, 2025	K250727	AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
February 27, 2025	K244043	AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup	NFT	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
September 27, 2024	K242540	AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel	NFT	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
December 13, 2023	K233019	AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx	DKZ	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
October 26, 2023	K233417	AllTest Fentanyl Urine Test Cassette	NGL	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov
July 31, 2023	K231698	AllTest Fentanyl Rapid Test (Urine)	DJG	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 4, 2025. 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.