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Data / Medical devices / China / Hangzhou AllTest Biotech Co.,Ltd

Hangzhou AllTest Biotech Co.,Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 14 510(k) clearances

Hangzhou AllTest Biotech Co.,Ltd is registered with the FDA (registration 3043127647) in Hangzhou Zhejiang, China. It lists 48 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 30, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Hangzhou AllTest Biotech Co.,Ltd
FDA registration number
3043127647
Address
No.616 Dongwei Road, Qiantang District, Hangzhou Zhejiang, China, 311222
Owner or operator
Hangzhou AllTest Biotech Co.,Ltd (10050156)
Roles
Contract manufacturer, Manufacturer
First device listed
July 28, 2017
Registered through
2027
Brand names listed
2SAN Fentanyl Urine Test Cassette, 2San Digital Early Pregnancy Test, 2San Early Result Pregnancy Test, 2San UTI Test, ACESO Early Pregnancy Test, ACRO Early Pregnancy Rapid Test, ACRO Fentanyl Urine Test, ACRO Fentanyl Urine Test Cassette and more

Devices it lists

DeviceProduct codeClassRoleSource
Antigens, All Groups, Streptococcus Spp.GTY1Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Manufactureraccessdata.fda.gov
Devices, Breath Trapping, AlcoholDJZ1Contract manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Contract manufacturer, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Contract manufacturer, Manufactureraccessdata.fda.gov
Paper, Obstetric PhLNW1Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Contract manufactureraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Manufactureraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Manufactureraccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Manufactureraccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Manufactureraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Manufactureraccessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, ExemptPVJ2Manufactureraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Manufactureraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Manufactureraccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Manufactureraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Manufactureraccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Manufactureraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Manufactureraccessdata.fda.gov
Test, Methaqualone, Employment And Insurance Testing, ExemptPVF2Manufactureraccessdata.fda.gov
Test, Morphine, Employment And Insurance Testing, ExemptPVG2Manufactureraccessdata.fda.gov
Test, Morphine, Over The CounterNGI2Manufactureraccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Manufactureraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Manufactureraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUManufactureraccessdata.fda.gov
Test, Propoxyphene, Employment And Insurance Testing, ExemptPVI2Manufactureraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MorphineDNK2Manufactureraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 30, 2026K260342AllTest Strep A Rapid TestGTYSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
October 30, 2025K252607AllTest Urinary Tract Infection TestJMTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
July 15, 2025K251053Shinetell PlusTM Digital Early Pregnancy TestLCXSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
April 4, 2025K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
April 4, 2025K242576AllTest Viral Transport MediumJSMSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
February 27, 2025K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
September 27, 2024K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
August 13, 2024K241978Shinetell Digital Pregnancy TestLCXSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
June 17, 2024K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
December 13, 2023K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxDKZSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
October 26, 2023K233417AllTest Fentanyl Urine Test CassetteNGLSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
July 31, 2023K231698AllTest Fentanyl Rapid Test (Urine)DJGSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
January 31, 2022K203272Alltest Pregnancy Rapid Combo Test CassetteJHISubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
March 27, 2019K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 30, 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.