Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: AUTODELFIA/DELFIA XPRESS HAFP
• Classification Name: kit, test, alpha-fetoprotein for neural tube defects
• Applicant: PERKINELMER, INC.
• PMA Number: P970037
• Supplement Number: S004
• Date Received: 02/02/2011
• Decision Date: 03/04/2011
• Product Code: LOK [ Registered Establishments with LOK ]
• Advisory Committee: Immunology
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in the supplier of a raw material.