Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberK212140
Test Name Medline Industries, LP, EvenCare G2 with Bluetooth Blood Glucose Monitoring System  
Manufacturer NameApex Biotechnology Corp.
Consumer Information Phone Number(866)274-2131
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/30/2023
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K212140
Device Name GlucoSure Link Blood Glucose Monitoring System
Applicant
Apex Biotechnology Corp.
No. 7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Applicant Contact Lisa Liu
Correspondent
Apex Biotechnology Corp.
No. 7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Correspondent Contact Lisa Liu
Regulation Number862.1345
Classification Product Code
NBW  
Date Received07/08/2021
Decision Date 08/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-