510(k) Premarket Notification

• Device Classification Name: system, test, blood glucose, over the counter
• 510(K) Number: K120866
• Model: DA01
• Device Name: DA01 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: DELBIO INCORPORATION; 3f, no. 252, shangying road; guishan industrial zone; taoyuan county,
• Contact: nicky pan
• Regulation Number: 862.1345
• Classification Product Code: NBW
• Subsequent Product Codes: CGA JJX
• Date Received: 03/22/2012
• Decision Date: 12/11/2012
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Clinical Chemistry
• Review Advisory Committee: Clinical Chemistry
• statement: statement
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No