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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 ARCHITECT AFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp-eia diagnostic kit
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS023
Date Received10/03/2007
Decision Date05/21/2008
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) creation of afp who primary calibrators and controls; 2) assay software changes: a) volume of sample in the pipetting protocol; b) dilution of specimen in the automated dilution protocols; and c) dilution parameters; 3) manual diluent change; and 4) new control concentrations.
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