510(k) Premarket Notification

• Device Classification Name: System, Test, Blood Glucose, Over The Counter
• 510(k) Number: K062058
• Device Name: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
• Applicant: BAYER HEALTHCARE; 430 SOUTH BEIGER STREET; MISHAWAKA, IN 46544
• Applicant Contact: ROGER SONNENBERG
• Correspondent: BAYER HEALTHCARE; 430 SOUTH BEIGER STREET; MISHAWAKA, IN 46544
• Correspondent Contact: ROGER SONNENBERG
• Regulation Number: 862.1345
• Classification Product Code: NBW
• Subsequent Product Code: LFR
• Date Received: 07/20/2006
• Decision Date: 09/11/2006
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Summary: Summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls