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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 KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantWALLAC OY
PMA NumberP970037
Supplement NumberS002
Date Received09/17/2008
Decision Date04/08/2009
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the production site or the two antibodies used in the autodelia hafp kit to wallac oy, turk, finland, and for a change in the antigen source in the hafp standards of the autodelia hafp kit.
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