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510(k) K160282

Device
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
Applicant
SD BIOSENSOR
510(k) number
K160282
Product code
NBW  
Decision
Substantially Equivalent (SESE)
Decision date
2017-10-17
Date received
2016-02-02
Regulation
862.1345
Classification name
System, Test, Blood Glucose, Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sunok Go
Address
C-4th & 5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-Si KR 443-813 443-813

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NBW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.2025-10-10
K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.2025-01-30
K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024-11-04
K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.2024-10-08
K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2024-08-27
K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.2024-08-16
K241304WaveSense Jazz Blood Glucose Monitoring SystemAgamatrix2024-06-06
K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care2024-02-23
K231192RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation2024-01-19
K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.2023-12-22
K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.2023-12-01
K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc.2023-08-10
K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH2023-08-10
K223722MIO Blood Glucose Monitoring SystemMio Labs, Inc.2023-06-28
K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.2022-12-21

Legacy Summary#

summary

FDA Review#

Decision Summary