510(k) Premarket Notification

• Device Classification Name: glucose oxidase, glucose
• 510(K) Number: K120921
• Models: M, S, VOICE+M, VOICE+S
• Device Name: CLEVER CHOICE
• Applicant: SIMPLE DIAGNOSTICS, INC.; 8870 ravello ct; naples, FL 34114
• Contact: daniel kamm
• Regulation Number: 862.1345
• Classification Product Code: CGA
• Subsequent Product Codes: JJX NBW
• Date Received: 03/27/2012
• Decision Date: 08/21/2012
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Clinical Chemistry
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Clinical Trials: NCT00976924
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No