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510(k) K161299

Device
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
Applicant
APEX BIOTECHNOLOGY CORP.
510(k) number
K161299
Product code
NBW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-23
Date received
2016-05-09
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
Hsue-mei Lee
Address
#7, Li-Hsin Rd. V, Hsinchu Science Park Hsinchu TW 30078 30078

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