510(k) Premarket Notification

• Device Classification Name: myoglobin, antigen, antiserum, control
• 510(K) Number: K122599
• Device Name: ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown, NY 10591
• Contact: kira gordon
• Regulation Number: 866.5680
• Classification Product Code: DDR
• Subsequent Product Code: JIT
• Date Received: 08/27/2012
• Decision Date: 10/03/2012
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Immunology
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No