Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2531491

FEI Number

3003516723

Entity Name

ACON LABORATORIES, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

9440 Carroll Park Dr, SAN DIEGO, CA 92121, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

ACON Laboratories, Inc. (Owner Number: 9063887)

Owner / Operator Contact Address

5850 Oberlin Drive, #340, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070929

PMA Number

N/A

All Registered 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 Mission U120 Smart Urine Analyzer Mission U120 Touch Urine Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2013-08-19
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2013-08-19
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2019-09-25
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-10-24
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-05-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-05-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-05-17
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-01-09
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-01-09
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-01-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-08
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2019-07-01
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2025-12-02
NGJ	Test, Nitrite, Urinary, Non-Quantitative, Over The Counter	Clinical Chemistry	Class 1	862.1510	2012-04-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2012-04-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-04-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2012-04-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2012-04-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2012-04-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-04-02
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2012-04-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2012-04-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2012-04-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2012-04-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2012-04-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-04-20
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-04-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-04-20
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-07-23
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-01-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-04-30
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-05-17
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2012-05-17
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-06-12
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-06-12
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-07-22
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-09-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-09-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-05-30
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-02-18
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2017-08-16
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2017-08-16
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2017-08-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-07
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-01-07
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2006-10-13
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2006-10-13
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2006-10-13
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2006-10-13
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2006-10-13
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2006-10-13
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2006-10-13
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2006-10-13
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2006-10-13
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2006-10-13
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2006-10-13
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2021-02-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-11-05
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-11-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-11-05
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2012-03-12
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2012-03-12
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2012-03-12
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-03-12
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2012-03-12
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2012-03-12
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2012-03-12
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2012-03-12
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-03-12
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2012-03-12
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2012-03-12
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2012-03-12
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-01-09
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-01-09
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-01-09
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-01-09
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-01-09
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-01-09
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-01-09
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-01-09
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-09
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-01-09
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-01-09

Official Correspondent

Catherine Shi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACON Laboratories, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017550662	MAQ-OPS, S. DE R.L.	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29
K936212	Heraeus Kulzer, Inc.	GLUCOFILM TEST STRIPS	1994-05-10
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2531491. Last updated year: 2026. Please use registration number 2531491 when referencing this establishment in official correspondence.