510(k) Premarket Notification

• Device Classification Name: method, nephelometric, immunoglobulins (g, a, m)
• 510(K) Number: K113823
• Models: NK625.T, NK626.T
• Device Name: HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
• Applicant: THE BINDING SITE GROUP LTD; 8 calthorpe road; edgbaston; birmingham, west midlands,
• Contact: jill constantine
• Regulation Number: 866.5510
• Classification Product Code: CFN
• Subsequent Product Codes: PDE PDF
• Date Received: 12/27/2011
• Decision Date: 03/27/2013
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Immunology
• Review Advisory Committee: Immunology
• statement: statement
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No