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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 NameAUOTDELFIA HAFP KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantPERKINELMER, INC.
PMA NumberP970037
Supplement NumberS007
Date Received09/28/2011
Decision Date04/27/2012
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change of the dispensing line used in the manufacturing of the calibrators for the autodelfia and delfia xpress hafp kits and the buffer solution for the delfia xpress hafp kit.
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