Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615507

FEI Number

3002829675

Entity Name

ACON BIOTECH (HANGZHOU) CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

No. 210 Zhenzhong Road, West Lake District, HANGZHOU Zhejiang 310030, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACON Laboratories Inc. (Owner Number: 9033096)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

On Call Pro Blood Glucose Monitoring System Mission U500 Urine Analyzer On Call Vivid Blood Glucose Monitoring System On Call Lancing Device On Call Stealth Lancing Device Test Yourself @ Home Digital Pregnancy Test HealthyMe® Digital Pregnancy Test Mission Plus Hemoglobin Testing System On Call Express Blood Glucose Monitoring System On Call Express II Blood Glucose Monitoring System KetoTrak Blood Ketone Monitoring System Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) Mission U120 Touch Urine Analyzer Mission U120 Touch Urine Analyzer On Call Express Voice Blood Glucose Monitoring System On Call Plus Blood Glucose Monitoring System HealthyMe® Early Detection Pregnancy Test Distinct® Early Detection Pregnancy Test On Call Diabetes Monitoring Software ACON URINALYSIS REAGENT STRIPS Mission Urinalysis Reagent Strips Mission Cholesterol CTRL Control Device Mission Cholesterol Test Device 3-in-1 Lipid Panel Mission Cholesterol Control Solution Mission Cholesterol Meter Mission U120 Smart Urine Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-09-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-09-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2012-04-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2012-04-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2012-04-02
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2012-04-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2012-04-02
NGJ	Test, Nitrite, Urinary, Non-Quantitative, Over The Counter	Clinical Chemistry	Class 1	862.1510	2012-04-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-04-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2012-04-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2012-04-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2012-04-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2012-04-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-04-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-05-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-05-17
CGA	Glucose Oxidase, Glucose	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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-05-17
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-04-15
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2013-08-19
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2013-08-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-01-07
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-01-07
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-01-07
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-06-26
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-06-26
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2015-07-10
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-07-10
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-01-29
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-01-29
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-01-29
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-01-29
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-01-29
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-01-29
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-01-29
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-01-29
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-01-29
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-01-29
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-01-29
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-06-26
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-07-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-10-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-10-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-10-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-06-06
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	2014-01-08
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2006-11-01
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2006-11-01
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2006-11-01
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2006-11-01
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2006-11-01
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2006-11-01
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2006-11-01
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2006-11-01
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2006-11-01
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2006-11-01
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2006-11-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2017-09-05
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2017-09-05
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2017-09-05
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2012-03-12
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	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
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	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
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2012-03-12
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2012-03-12
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2012-03-12
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2012-03-12
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2012-03-12
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-06-26

Official Correspondent

Catherine Shi

US Agent Details

Catherine Shi Business: ACON LABORATORIES INC. Email: cshi@aconlabs.com Phone: (858) 8758068

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
3032171519	Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou Zhejiang, CN

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
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

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 9615507. Last updated year: 2026. Please use registration number 9615507 when referencing this establishment in official correspondence.