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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 NumberS012
Date Received10/15/1997
Decision Date10/29/1997
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the labeling regarding limitations of the procedure.
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