EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042

System, Test, Blood Glucose, Over The Counter

EPS BIO TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easymax T1 Self Monitoring Blood Glucose System, Model Eps10042.

Pre-market Notification Details

• Device ID: K102345
• 510k Number: K102345
• Device Name: EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, TW 30077
• Contact: Y.c. Lei
• Correspondent: Y.c. Lei; EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, TW 30077
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-19
• Decision Date: 2011-06-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885017000409	K102345	000