ACON LABORATORIES, INC.

Registration Details

Registration Name: ACON LABORATORIES, INC.
Registration Number: 2531491
FEI Number: 3003516723
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 9440 Carroll Park Dr
City: SAN DIEGO
State: CA
ZIP: 92121
Country: US

Regulatory Submissions

510(k) Number: K122553

Owner / Operator

Firm Name: ACON Laboratories, Inc.
Operator Number: 9063887
Address: 5850 Oberlin Drive, #340
City: San Diego
State: CA
Postal Code: 92121
Country: US
Correspondent: Catherine Shi

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
System, Hemoglobin, Automated	GKR	Class 2	Hematology	No	2013-08-19
Control, Hemoglobin	GGM	Class 2	Hematology	No	2013-08-19
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	Class 1	Clinical Chemistry	No	2019-09-25
System, Test, Blood Glucose, Over The Counter	NBW	Class 2	Clinical Chemistry	No	2019-10-24
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2012-05-17
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2012-05-17
Test, Urine Leukocyte	LJX	Class 1	Hematology	No	2008-01-09
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	Class 1	Clinical Chemistry	No	2008-01-09
Calculator/Data Processing Module, For Clinical Use	JQP	Class 1	Clinical Chemistry	No	2014-01-08
Antigens, All Groups, Streptococcus Spp.	GTY	Class 1	Microbiology	No	2025-12-02
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter	NGJ	Class 1	Clinical Chemistry	No	2012-04-02
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	Class 1	Clinical Chemistry	No	2012-04-02
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	Class 1	Clinical Chemistry	No	2012-04-02
Refractometer For Clinical Use	JRE	Class 1	Clinical Chemistry	No	2012-04-02
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	Class 1	Clinical Chemistry	No	2012-04-02
Automated Urinalysis System	KQO	Class 1	Clinical Chemistry	No	2012-04-02
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	Class 1	Clinical Chemistry	No	2012-04-02
Blood, Occult, Colorimetric, In Urine	JIO	Class 2	Hematology	No	2012-04-02
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	Class 2	Clinical Chemistry	No	2012-04-02
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	Class 1	Clinical Chemistry	No	2012-04-02
Covid-19 Multi-Analyte Antigen Device	QMN	Class N	Unknown	No	2024-07-23
Over-The-Counter Covid-19 Antigen Test	QYT	Class 2	Microbiology	No	2024-01-02
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	Class 2	General, Plastic Surgery	No	2012-05-17
Enzymatic Method, Creatinine	JFY	Class 2	Clinical Chemistry	No	2015-06-12
Ldl & Vldl Precipitation, Hdl	LBR	Class 1	Clinical Chemistry	No	2017-08-16
Colorimetric Method, Triglycerides	JGY	Class 1	Clinical Chemistry	No	2017-08-16
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2017-08-16
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	Class 2	Clinical Chemistry	No	2021-02-16
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	Class 1	Clinical Chemistry	No	2021-06-22
Multi-Analyte Respiratory Virus Antigen Detection Test	SCA	Class 2	Microbiology	No	2025-11-18
Urinalysis Controls (Assayed And Unassayed)	JJW	Class 1	Clinical Chemistry	No	2011-07-15

Proprietary Names

Mission plus Hemoglobin Control Solution Mission Plus Hemoglobin Testing Systm CLIAwaived Inc. Hemoglobin Testing System AimStrip Hb Hemoglobin (Hb) Testing System KetoTrak Blood Ketone Monitoring System On Call Express II Blood Glucose Monitoring System On Call Vivid Blood Glucose Monitoring System Test Yourself @ Home Urinary Tract Infection Test Strips Vivoo At-Home Urinary Tract Infection Test HealthyMe Urinary Tract Infection Test Strips easy@Home Urinary Tract Infection Test Urinox Urinary Tract Infection Test Strips Mission UTI Urinary Tract Infection Test Strips On Call Diabetes Monitoring Software On Call Care Alliance Flowflex® Plus Strep A Rapid Test Strip Flowflex® Plus Strep A Rapid Test Cassette Mission U500 Urine Analyzer On Call Plus Blood Glucose Monitoring System Flowflex COVID-19 Antigen Home Test On Call Ketone Reagent Strips for Urinalysis On Call Stealth Lancing Device On Call Lancing Device Mission Urinalysis Reagent Strip (Microalbumin/Creatinine) Mission U120 Smart Urine Analyzer Mission U120 Touch Urine Analyzer On Call Express Voice Blood Glucose Monitoring System On Call Pro Blood Glucose Monitroring System On Call Express Mobile Blood Glucose Monitoring System On Call Sure Sync Blood Glucose Monitoring System On Call Sure Blood Glucose Monitoring System Mission Cholesterol Control Solution Mission Cholesterol Test Device 3-in-1 Lipid Panel Mission Cholesterol CTRL Control Device Mission Cholesterol Meter On Call Express Blood Glucose Monitoring System CAREONE Express Blood Glucose Monitoring System D-Care Leader LE1 Diathrive Blood Glucose Monitoring System ACON URINALYSIS REAGENT STRIPS Mission Urinalysis Reagent Strips Cliawaived Inc. Auto Urinalysis Reagent Strips Distinct® Early Detection Pregnancy Test HealthyMe® Early Detection Pregnancy Test Livongo® Glucose Control Solution Livongo® Blood Glucose Test Strips Teladoc Health Blood Glucose Test Strips Teladoc Health Glucose Control Solution HealthyMe® Ovulation Test Flowflex Plus RSV + Flu A/B + COVID Home Test Mission Liquid Urine Control Mission Liquid Diptube Urine Control Flowflex Plus COVID-19 + Flu A/B Home Test On Call Sure GK Blood Glucose and Ketone Monitoring System On Call Sure Sync GK Blood Glucose and Ketone Monitoring System HealthyMe® Digital Pregnancy Test Test Yourself @ Home Digital Pregnancy Test

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)