510(k) Premarket Notification

• Device Classification Name: fibrin split products
• 510(K) Number: K112120
• Model: DZ179A,DZ179A-CAL,DZ179A-CON
• Device Name: DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
• Applicant: DIAZYME LABORATORIES; 12889 gregg court; poway, CA 92064
• Contact: abhijit datta
• Regulation Number: 864.7320
• Classification Product Code: GHH
• Subsequent Product Codes: DAP JIT
• Date Received: 07/25/2011
• Decision Date: 01/24/2013
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Hematology
• Review Advisory Committee: Hematology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No