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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 HAFP TEST SYSTEM
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantPERKINELMER, INC.
PMA NumberP970037
Supplement NumberS008
Date Received05/17/2012
Decision Date06/14/2012
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 
Second alternative type of topo (trioctylphosphine oxide) raw material type used in the manufacturing of the enhancement solution for the device.
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