Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012133212

FEI Number

3012133212

Entity Name

SD BIOSENSOR, INC.

City/State/Country

Suwon-si Gyeonggi, KR

Establishment Address

C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si Gyeonggi 16690, KR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SD Biosensor, Inc. (Owner Number: 10035779)

Owner / Operator Contact Address

C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, KR-41 16690, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100398

PMA Number

N/A

All Registered Proprietary Names

Pilot COVID-19 At-Home Test STANDARD COVID-19 Ag Control Swab STANDARD Q COVID-19 Ag Test 2 STANDARD LipidoCare Control STANDARD GlucoNavii SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM SD CodeFree Catalogue Number 01GC11 Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-04-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-07-24
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2011-03-23
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-03-23

Official Correspondent

Hyo-Keun Lee

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

SD Biosensor, 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
3008959428	SD Biosensor, Inc.	Cheongju-si Chungbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
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.
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

Similar Registrations

Registration Number	Establishment Name	Location
3043128348	Shenzhen Yang Biotech Co., Ltd.	Shenzhen Guangdong, CN
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012133212. Last updated year: 2026. Please use registration number 3012133212 when referencing this establishment in official correspondence.