FDA Device Registration & Listing · KOWLOON, HK · Registration 3010852191
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| SDV | Clinical Electronic Thermometer | General Hospital | Class 2 | 880.2910 | 2025-07-11 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 2023-04-21 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | Class 1 | 862.1300 | 2023-06-30 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | Obstetrics/Gynecology | Class 2 | 884.5300 | 2024-01-16 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | Class 1 | 862.1485 | 2022-10-09 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | Class 2 | 882.5890 | 2023-04-13 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2023-04-21 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2024-01-16 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-04-20 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2024-08-25 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2022-10-09 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-04-20 |
| KNG | Monitor, Ultrasonic, Fetal | Obstetrics/Gynecology | Class 2 | 884.2660 | 2023-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2023-04-07 |
| KNG | Monitor, Ultrasonic, Fetal | Obstetrics/Gynecology | Class 2 | 884.2660 | 2023-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-04-20 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2023-04-13 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-04-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-04-07 |
| LNW | Paper, Obstetric Ph | Clinical Chemistry | Class 1 | 862.1550 | 2023-07-31 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | Class 2 | 890.5850 | 2023-04-13 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | Class 2 | 882.5890 | 2023-04-13 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2022-10-09 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2023-04-20 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2023-04-21 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2023-04-21 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-21 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2023-04-21 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2023-04-21 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2023-04-21 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2023-04-21 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-21 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2023-04-21 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2023-04-21 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2023-04-21 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2023-04-20 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2025-04-21 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-21 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2023-11-05 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2023-11-05 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2023-11-05 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2023-04-21 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-21 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2023-04-21 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2023-04-21 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2023-04-21 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2023-04-21 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2023-04-21 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2023-04-21 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-21 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2023-04-21 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2023-04-21 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2023-04-21 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2023-04-21 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2022-10-09 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2022-10-09 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2022-10-09 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2023-04-21 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-21 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2023-04-20 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | Class 2 | 882.5890 | 2023-04-07 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | Class 2 | 890.5850 | 2023-04-07 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2023-04-21 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2023-04-21 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2023-04-21 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-21 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-21 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2023-04-21 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2023-04-21 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2023-04-21 |
| MRS | Test System, Nicotine, Cotinine, Metabolites | Clinical Toxicology | Class 1 | 862.3220 | 2023-04-21 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | Class 2 | 890.5850 | 2022-10-09 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | Class 2 | 882.5890 | 2022-10-09 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | Class 2 | 882.5890 | 2022-10-09 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | Class 1 | 862.1510 | 2024-05-07 |
| LJX | Test, Urine Leukocyte | Hematology | Class 1 | 864.7675 | 2024-05-07 |
| KNG | Monitor, Ultrasonic, Fetal | Obstetrics/Gynecology | Class 2 | 884.2660 | 2023-04-20 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2023-04-21 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-21 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-21 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2023-04-21 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2023-04-21 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2023-04-21 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2023-04-21 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2023-04-21 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2023-04-21 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2023-04-21 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2023-04-21 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2023-04-21 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2024-12-20 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2025-07-02 |
| 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 |
| K964108 | Direct Access Diagnostics | FACT PLUS PREGNANCY TEST | 1996-11-18 |
| K945514 | Princeton BioMeditech Corp. | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | 1995-02-10 |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | 2015-08-07 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0043-2024 | Universal Meditech Inc. | 1 | One Step Ovulation Test REF 200-01 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3030989301 | TRIMEDIKA LTD | Belfast Mid Ulster, GB |
| 3021042343 | HUAIAN ZHONGXIN PACKING MATERIAL CO., LTD. | Huaian Jiangsu, CN |
| 3007499349 | VERIDIAN HEALTHCARE | Gurnee, IL, US |
| 3008573045 | Andon Medical co., LTD | Tianjin, CN |
| 3016670149 | GUANGDONG GENIAL TECHNOLOGY CO., LTD. | Zhaoqing Guangdong, CN |
3010852191 when referencing this establishment in official correspondence.