510(k) Premarket Notification

• Device Classification Name: hexokinase, glucose
• 510(K) Number: K120369
• Device Name: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
• Applicant: HITACHI CHEMICAL DIAGNOSTICS, INC.; 630 clyde ct.; mountain view, CA 94043
• Contact: bunichiro nakajima
• Regulation Number: 862.1345
• Classification Product Code: CFR
• Date Received: 02/06/2012
• Decision Date: 05/10/2012
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Clinical Chemistry
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No