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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 NameARCHITECT AFP ASSAY
Classification Namekit, test, alpha-fetoprotein for neural tube defects
ApplicantABBOTT LABORATORIES
PMA NumberP120008
Supplement NumberS002
Date Received02/19/2013
Decision Date08/27/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for migration of architect afp assay to the architect i system family member, the architect il000sr.
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