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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 NameAXSYM AFP (LN 7A48)
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-eia diagnostic kit
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS030
Date Received11/02/2011
Decision Date12/22/2011
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 relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
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