Search Results
Found 1 results
510(k) Data Aggregation
K Number
K170264Device Name
Gold AQ Blood Glucose Monitoring System
Manufacturer
Changsha Sinocare Inc.
Date Cleared
2017-10-05
(251 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Changsha Sinocare Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gold AQ Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. It is intended to be used by people with diabetes at home as an aid in monitoring the effectiveness of their diabetes control programs.
The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip. The Gold AQ Blood Glucose Monitoring System is for seff-testing outside the body (in vitro diagnostic use).
The Gold AO Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Gold AQ Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for diabetes. It is not intended for use on neonates.
Device Description
The Gold AQ Blood Glucose Monitoring System is comprised of the Gold AQ blood glucose meter and the Gold AQ blood glucose test strip.
Ask a Question
Page 1 of 1