BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

ANDON MEDICAL CO., LTD

The following data is part of a premarket notification filed by Andon Medical Co., Ltd with the FDA for Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K120813
• 510k Number: K120813
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: ANDON MEDICAL CO., LTD NO. 26 HANG YU ROAD TIANJIN AIRPORT ECONOMIC AREA Tianjin, CN 300381
• Contact: Yi Liu
• Correspondent: Yi Liu; ANDON MEDICAL CO., LTD NO. 26 HANG YU ROAD TIANJIN AIRPORT ECONOMIC AREA Tianjin, CN 300381
• Product Code: NBW
• Subsequent Product Code: CGA
• Subsequent Product Code: JQP
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-19
• Decision Date: 2012-12-07
• Summary: summary