OSANG Healthcare CO., LTD.

FDA Device Registration & Listing · ANYANG Gyeonggi, KR · Registration 3004146366

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
3004146366
FEI Number
3004146366
Entity Name
OSANG Healthcare CO., LTD.
City/State/Country
ANYANG Gyeonggi, KR
Establishment Address
132, Anyangcheondong-ro, DONGAN-GU, ANYANG Gyeonggi 14040, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OSANG HEALTHCARE CO., LTD. (Owner Number: 9056376)
Owner / Operator Contact Address
132, Anyangcheondong-ro, Dongan-gu, Anyang, KR-41 14040, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243262
PMA Number
N/A

All Registered Proprietary Names

Finetest Lite G5 Infinity™ OHC COVID-19 Antigen Self Test Myglucohealth LDE4 Lancing Device GeneFinder COVID-19 Plus RealAmp Kit Easygluco G2 OKRA Pro OKRA REFILL KIT OKRA Test Strip Control AST G3 Oh'Care Lite CURO L5 Member Mark BluLink Disposable Blood Lancet QuickFinder™ COVID-19/Flu Antigen Self Test BinaxNOW™ COVID-19/Flu A&B BinaxNOW™ COVID-19/Flu A&B Combo Self Test QuickFinder™ COVID-19/Flu Antigen Pro Test

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 2024-11-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-07-14
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-07-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-07-14
QYT Over-The-Counter Covid-19 Antigen Test Microbiology Class 2 866.3984 2025-06-09
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-03-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-03-03
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-03-03
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2026-05-26
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-04-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-07-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-07-14
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-07-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-04-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-07-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-07-14
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-17
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-12-17
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-06-26
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2013-06-26
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2013-06-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-06-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-06-26
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2013-06-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-10-28
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-04-02
SCA Multi-Analyte Respiratory Virus Antigen Detection Test Microbiology Class 2 866.3987 2025-01-14

Official Correspondent

Chulhun Kang

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 2025789

Related Public Records

Same Entity

OSANG HEALTHCARE CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3020885868 OSANG LLC S Pasadena, CA, US

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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

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-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004146366. Last updated year: 2026. Please use registration number 3004146366 when referencing this establishment in official correspondence.
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