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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 AXSYM AFP
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp-eia diagnostic kit
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS019
Date Received08/14/2003
Decision Date02/02/2004
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in protocol for the automated dilution protocol in abbott axsym software version 3. 60 and version 4. 01.
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