Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024463179

FEI Number

3024463179

Entity Name

ACESO LABORATORIES INC.

City/State/Country

Chino, CA, US

Establishment Address

14020 Central Ave, Suite 520, Chino, CA 91710, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aceso Laboratories Inc. (Owner Number: 10085983)

Owner / Operator Contact Address

14020 Central Ave, Suite 520, Chino, CA 91710, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251053

PMA Number

N/A

All Registered Proprietary Names

Atida Viral Transport Medium Lactoferrin Test Atida Multiplex Drug of Abuse Test Cup Atida Multiplex Drug of Abuse Cup Test LH Ovulation Test Atida Pregnancy Test Norovirus Test Atida Fentanyl Drug of Abuse Test Rx Vibrio cholerae O139 (VC O139) Test Vibrio cholerae O1/O139 Combo Test Vibrio cholerae O1 (VC O1) Test Urinalysis Reagent Strips - 1-14 parameters Insulin-like Growth Factor-binding Protein 1 (iGFBP-1) Test Urinalysis Reagent Strips - 1-14 parameters Typhoid IgG/IgM Test Salmonella typhi Ag Test Mycoplasma pneumoniae Ag Test Strep A Test Atida Fentanyl Test Atida Fentanyl Drug of Abuse Test Atida Urinary Tract Infection Test Entamoeba histolytica Test Brucella Abortus Ag Test ACESO Early Pregnancy Test Atida Early Pregnancy Test Atida Multiplex Drug of Abuse Cup Test Atida Multiplex Drug of Abuse Dip Card Test Rx Atida Multiplex Drug of Abuse Dip Card Test Atida Multiplex Drug of Abuse Cup Test Rx Rotavirus & Adenovirus Combo Test Rotavirus Test Giardia Lamblia Test Urinalysis Reagent Strips - 1-14 parameters Urinalysis Reagent Strips - 1-14 parameters Vaginal pH Test Atida Digital Pregnancy Test Cotinine (COT) Test Legionella pneumophila Test LH Ovulation Test Clostridium difficile Toxin A &Toxin B Combo Test Urinalysis Reagent Strips - 1-14 parameters Urinalysis Reagent Strips - 1-14 parameters Micro-Albumin Semi-Quantitative Test Micro-Albumin Test Urinalysis Reagent Strips -1-14 parameters Urinalysis Reagent Strips - 1-14 parameters Cryptosporidium Test Adenovirus Test Atida Multiplex Drug of Abuse Rapid Urine Cup Test Atida Multiplex Drug of Abuse Urine Cup Test Atida Digital Early Pregnancy Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2025-05-14
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2024-05-13
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-05-14
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-05-14
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-05-14
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-05-14
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2025-05-14
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-05-14
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-05-14
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-05-14
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-05-14
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-05-14
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-05-14
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-05-14
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-07-24
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-05-10
OUC	Norovirus Serological Reagent	Microbiology	Class 2	866.3395	2024-05-13
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-05-10
GSQ	Antiserum, Vibrio Cholerae, All Varieties	Microbiology	Class 2	866.3930	2024-05-13
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2024-05-13
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2024-05-13
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2024-05-13
GRL	Antigens, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2024-05-13
GSB	Antigens, Cf, All, Mycoplasma Spp.	Microbiology	Class 1	866.3375	2024-05-13
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2024-05-13
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-05-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-05-10
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2026-03-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2026-03-18
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	Class 2	866.3220	2024-05-13
GSO	Antigens (Febrile), Agglutination, Brucella Spp.	Microbiology	Class 2	866.3085	2024-05-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-04-09
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-05-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-05-10
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2024-05-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-05-10
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-05-10
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-05-10
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-05-10
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-05-10
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-05-10
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-05-10
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-05-10
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2024-05-10
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-05-10
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-05-10
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2024-05-10
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-05-10
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-05-10
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-05-10
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-05-10
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-05-10
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-05-10
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-05-10
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-05-10
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Microbiology	Class 1	866.3405	2024-05-13
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2024-05-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-05-13
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2024-05-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-01-14
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2024-05-13
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	Class 2	866.3300	2024-05-13
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2022-10-07
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2024-05-13
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-05-13
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-05-13
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2024-05-13
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-05-13
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-05-13
MHJ	Cryptosporidium Spp.	Microbiology	Class 2	866.3220	2024-05-13
GOD	Antigens, Cf (Including Cf Control), Adenovirus 1-33	Microbiology	Class 1	866.3020	2024-05-13
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-01-14
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-01-14
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-01-14
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-01-14
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-01-14
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-01-14
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-01-14
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-01-14
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-01-14
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-01-14
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aceso Laboratories Inc.

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
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K252550	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18
K202567	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	2020-09-25
K260065	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	2026-04-28
K182701	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Cup Multi-Drug Urine Test Cup	2018-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024463179. Last updated year: 2026. Please use registration number 3024463179 when referencing this establishment in official correspondence.