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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 TEST SYSTEM
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantPERKINELMER, INC.
PMA NumberP970037
Supplement NumberS006
Date Received06/13/2011
Decision Date06/24/2011
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the topo (trioctylphosphine oxide) raw material type used in the manufacturing of the delfia inducer.
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