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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameAUTODELFIA/DELFIA XPRESS HAFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantPERKINELMER, INC.
PMA NumberP970037
Supplement NumberS004
Date Received02/02/2011
Decision Date03/04/2011
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-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.
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