TAIDOC TECHNOLOGY CORPORATION

FDA Device Registration & Listing · New Taipei City, TW · Registration 3004145393

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004145393
FEI Number
3004145393
Entity Name
TAIDOC TECHNOLOGY CORPORATION
City/State/Country
New Taipei City, TW
Establishment Address
B1-7F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City 24888, TW
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
TAIDOC TECHNOLOGY CORPORATION (Owner Number: 9058384)
Owner / Operator Contact Address
B1-7F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, TW-NOTA 24888, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142664
PMA Number
N/A

All Registered Proprietary Names

TD-4267 Blood Glucose Monitoring System ANKOVO TD-4267 Blood Glucose Monitoring System Clever TD-1112 Series Ear/Skin/Surface IR Thermometer ri-thermo® tymPRO Tympanic Thermometer FORA IR20b Ear Thermometer U-RIGHT TD-1118 Ear Thermometer FORA IR18 Ear Thermometer Caregiver PRO-TF300 TD-1241 Thermometer TaiDoc TD11 Series Ear/Skin/Surface IR Thermometers FORA IR17 Ear Thermometer Clever TD-1112 Ear/Skin/Surface IR Thermometer FORA IR42 Forehead Thermometer ION Health USB Insta-Scan Thermometer TD-1261 Thermometer U-RIGHT TD-1240 Thermometer MEDLINE No Touch Forehead Thermometer Uright TD-1242 Forehead Thermometer TaiDoc TD-11 Series Ear/Skin/Surface IR Thermometer U-RIGHT TD-1115 Ear Thermometer KODAK Infrared Thermometer DIRECT SUPPLY Attendant ACIT-1 Connected Infrared Thermometer FORA ComfortScan Ear Thermometer TD-1261A FORA IR20 Ear Thermometer FORA IR16 Ear Thermometer Digital Thermometer TD-1261 Infrared Ear/Forehead Thermometer U-Right Forehead Thermometer FORA IR42d Forehead Thermometer QARDIO Forehead Thermometer FORA IR22 Ear Thermometer Clever Forehead Thermometer CLEVER TD-1242 Forehead Thermometer Fora Comfort 4 in 1 Ear Thermometer MbH TD-1242 Non-Contact Forehead Thermometer Clever TD-1107 Ear/Skin/Surface IR Thermometer Caregiver non-contact thermometer Masimo TIR-1 Non-Contact Thermometer Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) ri-thermo® sensioPRO+ Non-Contact Thermometer Nexus IR30 Thermometer TD-1261B DIRECT SUPPLY Attendant ACTT-1 Tympanic Thermometer Caregiver professional clinical thermometer Clever TD-1107 Ear Infrared Thermometer ri-thermo® sensioPRO Non-Contact Thermometer FORA IR21b Ear Thermometer GRX Forehead Thermometer FORA ConfortScan Ear Thermometer ri-thermo® tymPRO+ Tympanic Thermometer TD-4258 POCT Blood Glucose Monitoring System Rosie RealTime Blood Glucose Monitoring System FORA TN'G Voice Blood Glucose Monitoring System TD-4277 Blood Glucose Monitoring System FORA GD50 Blood Glucose Monitoring System FORA Test N'GO Voice Blood Glucose Monitoring System UltraTRAK Ultimate Blood Glucose Monitoring System TD-4287 Blood Glucose Monitoring System GlucoRx Nexus Blood Glucose Monitoring System FORA Diamond Voice Blood Glucose Monitoring System URight TD-4277 Blood Glucose Monitoring System LIVE TULA 1 Blood Glucose Monitoring System ForaCare GD20 Blood Glucose Monitoring System HanrayCare Blood Glucose Monitoring System FORA TeleHealth System Pro Voice V8 Blood Glucose Monitoring System U-RIGHT TD-4235 Blood Glucose Monitoring System FORA G22 Blood Glucose Monitoring System FORA G21 Blood Glucose Monitoring System TD-4207 Blood Glucose Monitoring System ACHTUNG Blood Glucose Monitoring System metene S Blood Glucose Monitoring System U-RIGHT TD-3128 Blood Pressure Monitoring System ri-champion® smartPRO Blood Pressure Monitor Dario Blood pressure monitoring system (Model: DH-1165) TD-3128 Blood Pressure Monitoring System ri-champion® smartPRO+ Blood Pressure Monitor Snotty Boss Battery Powered Nasal Aspirator Kit TD-4268 Blood Glucose Monitoring System TD-4268 Multi Blood Glucose Monitoring System TD-4239 Multi Blood Glucose Monitoring System TD-4239 Blood Glucose Monitoring System FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System FORA MD6 Pro Uric Acid Monitoring System E1 Uric Acid Monitoring system FORA MD6 Uric Acid Monitoring System HeartsCare C1 Uric Acid Monitoring System URIGHT ADVANCE Arm Blood Pressure Monitor FORA P30 Blood Pressure Monitoring System FORA P30 Plus Multi-Mode Blood Pressure Monitoring System FORA P30 Plus Blood Pressure Monitoring System FORA P30 Plus BLE Blood Pressure Monitoring System Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System ActiveCare TD-4121 Blood Glucose Monitoring System FORA G20 Blood Glucose Monitoring System FORA TD-4251 No-Coding Blood Glucose Monitoring System FORA GD20 Blood Glucose Monitoring System Rapid Response™ Gluco-MD Blood Glucose Monitoring System UltraTRAK Complete Blood Glucose Monitoring System Clever Chek TD-4231 Blood Glucose Monitoring System V-TRUST Handheld Pulse Oximeter V-TRUST TD-8201 Handheld Pulse Oximeter Uric Acid Meter TD-4141 Uric Acid Monitoring System heartscare C1 monitoring system heartscare C1 uric acid Clever TD-7001 Nebulizer Uright TD-7001 Mesh Nebulizer SootheNeb NBL100 Mesh Nebulizer FORA TN'G Blood Glucose Monitoring System U-Right TD-4283 Blood Glucose Monitoring System FORA Diamond Prima Blood Glucose Monitoring System FORA Diamond Mini Blood Glucose Monitoring System FORA V30 Blood Glucose Monitoring System FORA Control Solutions TaiDoc Control Solutions FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System FORA GTel Multi-Functional Monitoring System Heartscare C1 Plus heartscare C1 total cholesterol heartscare C1 monitoring system FORA P20 Blood Pressure Monitor FORA P20 Blood Pressure Monitoring System GlucoX GX1 Blood Glucose Plus ?-Ketone Monitoring System VTrust TD-4279 Blood Glucose plus ?-Ketone Monitoring System FORA ADVANCED GD40 pro Blood Glucose and ?-Ketone Monitoring System FORA ADVANCED GD40 Blood Glucose and ?-Ketone Monitoring System FORA Test N'GO Advance Voice Multi-Functional Monitoring System VTrust Pro TD-4279 Blood Glucose plus ?-Ketone Monitoring System TD-4278 Multi-Functional Monitoring System Lucidplus Ref. No.300300 Blood Glucose Plus ?-Ketone Monitoring System TD-4183 Blood Glucose Plus ?-Ketone Monitoring System STAT-Site WB Dual Analyte Measurement System FORA 6 Plus Multi-Functional Monitoring System Uright TD-4206 Blood Glucose and ?-Ketone Monitoring System gojji Multi-Functional Monitoring System Bruno MD6 Multi-Functional Monitoring System FORA Test N'GO Advance Multi-Functional Monitoring System Trister (TS 021BGK) blood glucose and ?-ketone monitoring system Tricella Trio Smart Monitoring System bkt ?-ketone & blood glucose monitoring system FORA Test N'GO Adv. Mobile Multi-Functional Monitoring System Dario Multi-Functional Monitoring System (Dario MF) XPER Technology I1 Multi-Functional Monitoring System gojji Plus Test N'GO Advance+ Multi-Functional Monitoring System Ketodoc Blood Glucose Plus ?-Ketone Monitoring System SureMediks ?-ketone & blood glucose monitoring system VTRUST Vital Signs Monitor FORA Vital Signs Monitor FORA VSM100 Pro Vital Signs Monitor FORA G30a Blood Glucose Monitoring System FORA G30 Blood Glucose Monitoring System ForaCare G30 Blood Glucose Monitoring System U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System FORA MD Control Blood Glucose Monitoring System FORA GD40a Blood Glucose Monitoring System U-RIGHT TD-4279B Blood Glucose Monitoring System FORA GD40b Blood Glucose Monitoring System FORA Wisdom GD40a Blood Glucose Monitoring System FORA MD Blood Glucose Monitoring System TD-4272b Blood Glucose Monitoring System FORA Wisdom GD40b Blood Glucose Monitoring System TD-4272a Blood Glucose Monitoring System U-RIGHT TD-4279A Blood Glucose Monitoring System XPER Technology I1 (TD-4289) Blood Glucose Monitoring System U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System U-RIGHT TD-4116 Pro Blood Glucose Monitoring System U-RIGHT TD-4116 Blood Glucose Monitoring System metene blood glucose monitoring system FORA TN'G Scale 550 gojji Weight Scale GRX Scales Blue FORA Test N’GO Scale Mobile FORA G70 Blood Glucose Monitoring System Ultra Trak Active Blood Glucose Monitoring System FORA GD20 Blood Glucose Monitoring System FORA Control Solution ForaCare GD20 Blood Glucose Monitoring System FORA D40d Blood Glucose plus Blood Pressure Monitoring System FORA D40 Pro Blood Glucose plus Blood Pressure Monitoring System Medisante BP800 3G Blood Glucose Plus Blood Pressure Monitoring System FORA D40g Blood Glucose plus Blood Pressure Monitoring System FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System TD-3261 Blood Glucose plus Blood Pressure Monitoring System avokaid TD-3261 Blood Glucose Plus Blood Pressure Monitoring System FORA D40g Plus Blood Glucose Plus Blood Pressure Monitoring System U-Right TD-4285 Blood Glucose Monitoring System FORA Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250 FORA D20 Blood Glucose Plus Blood Pressure Monitoring System FORA Premium V12 Blood Glucose Monitoring System FORA Premium V12 Voice Blood Glucose Monitoring System LIVE TULA Sterile lancets TD-5010 Lancing Device ; TD-THIN Sterile Lancets FORA gojji LANCING DEVICE ; FORA gojji STERILE LANCETS TD-5011 Lancing Device ; TD-THIN Sterile Lancets FORA LANCING DEVICE ; FORA STERILE LANCETS Live Tula-Lancing device U-RIGHT Compressor Nebulizer U-RIGHT TD-7014 Compressor Nebulizer SootheNeb NBL200 Compressor Nebulizer Direct Supply Attendant Handheld Nebulizer SootheNeb NBL300g Compressor Nebulizer SootheNeb NBL300b Compressor Nebulizer FORA Premium V10 Blood Glucose Monitoring System FORA Premium V10 BLE Blood Glucose Monitoring System U-RIGHT TD-3135 Blood Pressure Monitoring System FORA P50 Blood Pressure Monitoring System Vital Signs Monitor TD-3252 Blood Glucose Plus Blood Pressure Monitoring System FORA O2 Fingertip Pulse Oximeter Finger Type Pulse Oximeter MbH (Mobile Health) Fingertip Pulse Oximeter FORA TN'G SpO2 GRX Pluse Oximeter Pre VTRUST TD-8255 Fingertip Pulse Oximeter FORA Pulse Oximeter TD-5052 AKTIVSAFE LANCET (Sterile) FORA A1C100 Rapid Response Hemoglobin A1c System FORA A1c System U-Right Hemoglobin A1c System

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 2010-05-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-05-19
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-07-21
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-07-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-08-05
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2010-08-05
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-08-05
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-05-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-05-26
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2009-10-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-03-07
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-03-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2012-01-17
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2018-12-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-02-20
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-02-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-09-12
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-09-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
PTC Uric Acid Test System For At Home Prescription Use Clinical Chemistry Class 1 862.1775 2018-12-11
LFQ Acid, Uric, Acid Reduction Of Ferric Ion Clinical Chemistry Class 1 862.1775 2018-12-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-07-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2009-10-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-07-16
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-02-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-02-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-12-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-12-20
DQA Oximeter Cardiovascular Class 2 870.2700 2011-07-13
LFQ Acid, Uric, Acid Reduction Of Ferric Ion Clinical Chemistry Class 1 862.1775 2018-01-03
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2013-06-17
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2012-02-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-02-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-05-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-05-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-08-05
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2022-06-21
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2022-06-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-06-21
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2021-05-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-02-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-11-15
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2016-11-15
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2016-11-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-11-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2018-06-11
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2018-06-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-06-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-06-11
DQA Oximeter Cardiovascular Class 2 870.2700 2018-06-11
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2018-06-11
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2018-06-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-07-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-07-11
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-07-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-07-08
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2011-05-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-02-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-02-22
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-08-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-09-12
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2011-09-12
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-09-12
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-12-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2011-12-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-12-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-08-05
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-12-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-12-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-12-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-02-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-02-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-02-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-10-21
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-10-21
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-01-30
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-01-30
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2013-06-17
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-12-27
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-12-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2012-01-05
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2010-08-05
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2010-05-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-05-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-05-19
DQA Oximeter Cardiovascular Class 2 870.2700 2016-03-03
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2022-06-23
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-08-21
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2017-08-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-08-21

Official Correspondent

MIKE CHEN

US Agent Details

Sophia Wu Business: ForaCare Inc Email: sophia-agent@foracare.com Phone: (805) 4988188

Related Public Records

Same Entity

TAIDOC TECHNOLOGY CORPORATION
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
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
K973662 Boehringer Mannheim Corp. ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS 1997-12-15

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 3004145393. Last updated year: 2026. Please use registration number 3004145393 when referencing this establishment in official correspondence.
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