510(k) Premarket Notification

• Device Classification Name: chronic lymphocytic leukemia fish probe kit
• 510(K) Number: K962873
• Device Name: CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
• Applicant: VYSIS; 3100 woodcreek dr.; downers grove, IL 60515
• Contact: russel k enns
• Regulation Number: 866.6040
• Classification Product Code: OVQ
• Subsequent Product Code: KIR
• Date Received: 07/23/1996
• Decision Date: 01/13/1997
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Immunology
• Review Advisory Committee: Immunology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No