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Data / Medical devices / China / Guangzhou Decheng Biotechnology Co., Ltd.

Guangzhou Decheng Biotechnology Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 7 510(k) clearances

Guangzhou Decheng Biotechnology Co., Ltd. is registered with the FDA (registration 3017904598) in Guangzhou Guangdong, China. It lists 36 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 9, 2025. Registered through 2026. FDA data exported November 3, 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 Guangzhou Decheng Biotechnology Co., Ltd.
FDA registration number
3017904598
Address
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District, Guangzhou Guangdong, China, 510663
Owner or operator
Guangzhou Decheng biotechnology co., Ltd. (10079520)
Roles
Complaint file establishment, Exporter to the US, Manufacturer
First device listed
June 1, 2021
Registered through
2026
Brand names listed
AllSource DRUG DETECTOR, Amazewell™ Early Detection Pregnancy Test Midstream, Amazewell™ Early Detection Pregnancy Test Strip, Amazewell™ D-Pen™ Mini COT Oral Fluid Test, Amazewell™ D-Pen™ Mini THC Oral Fluid Test, Amazewell™ D-Pen™ Oral Fluid Drug Test, Amazewell™ Digital Ovulation Test Kit, Amazewell™ Digital Pregnancy Rapid Test and more

Devices it lists

DeviceProduct codeClassRoleSource
Enzyme Immunoassay, AmphetamineDKZ2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Complaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUComplaint file establishment, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Complaint file establishment, Manufactureraccessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The CounterQKE1Complaint file establishment, Manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Radioimmunoassay, EstroneCGF1Manufactureraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Complaint file establishment, Manufactureraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, ExemptPVJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Manufactureraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUComplaint file establishment, Manufactureraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Complaint file establishment, Manufactureraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Complaint file establishment, Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Complaint file establishment, Manufactureraccessdata.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
September 9, 2025K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestLCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
February 6, 2025K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusNGLSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
June 21, 2024K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
May 10, 2024K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJGSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
December 13, 2023K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupDJGSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
February 28, 2023K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov
November 30, 2022K222305MissLan™ Digital Pregnancy Rapid TestLCXSubstantially EquivalentGuangzhou Decheng Biotechnology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 9, 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.