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Data / Medical devices / United States / Aceso Laboratories Inc.

Aceso Laboratories Inc.: FDA-registered device maker in Chino, CA, United States, 15 510(k) clearances

Aceso Laboratories Inc. is registered with the FDA (registration 3024463179) in Chino, CA, United States. It lists 59 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 30, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aceso Laboratories Inc.
FDA registration number
3024463179
Address
14020 Central Ave Suite 520, Chino, CA, United States, 91710
Owner or operator
Aceso Laboratories Inc. (10085983)
Roles
Manufacturer
First device listed
October 7, 2022
Registered through
2027
Brand names listed
ACESO Early Pregnancy Test, Adenovirus Test, Atida Digital Early Pregnancy Test, Atida Digital Pregnancy Test, Atida Early Pregnancy Test, Atida Fentanyl Drug of Abuse Test, Atida Fentanyl Drug of Abuse Test Rx, Atida Fentanyl Test and more

Devices it lists

DeviceProduct codeClassRoleSource
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Antigen, Id, Candida AlbicansLHK2Manufactureraccessdata.fda.gov
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.KHW2Manufactureraccessdata.fda.gov
Antigens (Febrile), Agglutination, Brucella Spp.GSO2Manufactureraccessdata.fda.gov
Antigens, All Groups, Salmonella Spp.GRL2Manufactureraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Manufactureraccessdata.fda.gov
Antigens, All, Leptospira Spp.GRY2Manufactureraccessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33GOD1Manufactureraccessdata.fda.gov
Antigens, Cf, All, Mycoplasma Spp.GSB1Manufactureraccessdata.fda.gov
Antiserum, Vibrio Cholerae, All VarietiesGSQ2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufactureraccessdata.fda.gov
Cryptosporidium Spp.MHJ2Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Manufactureraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Manufactureraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Manufactureraccessdata.fda.gov
Giardia Spp.MHI2Manufactureraccessdata.fda.gov
Immunoassay, Insulin-Like Growth Factor Binding Protein-1OAM1Manufactureraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Manufactureraccessdata.fda.gov
Lactoferrin, Antigen, Antiserum, ControlDEG1Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Norovirus Serological ReagentOUC2Manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Manufactureraccessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect FluorescentLHL2Manufactureraccessdata.fda.gov
Reagents, Clostridium Difficile ToxinLLH1Manufactureraccessdata.fda.gov
Seminal Fluid, Antigen, Antiserum, ControlDGB1Manufactureraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Manufactureraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Manufactureraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Manufactureraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Manufactureraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Manufactureraccessdata.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, Over The CounterPTG2Manufactureraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Manufactureraccessdata.fda.gov
Test, Morphine, Over The CounterNGI2Manufactureraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Manufactureraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMUManufactureraccessdata.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
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
April 5, 2024K234152ACESO Early Pregnancy TestLCXSubstantially EquivalentAceso Laboratories, Inc.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
May 18, 2018K180771Acro HCG Pregnancy Rapid TestLCXSubstantially EquivalentAcro Biotech, Inc.accessdata.fda.gov

Compare with other makers

Updated October 30, 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.