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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 NameABBOTT AFP-EIA DIAGNOSTIC KIT
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-eia diagnostic kit
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS021
Date Received01/17/2007
Decision Date02/01/2007
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 
Consolidation of secondary packaging operations from building k2 located in the k-complex to building ap32 located in abbott park.
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