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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT AXSYM AFP (LIST 7A48)
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Namekit, test,alpha-fetoprotein for testicular cancer
Regulation Number866.6010
Applicant
Abbott Laboratories
100 abbott park rd.
ap5n-2, dept. 09vb
abbott park, IL 60064-3500
PMA NumberP820060
Supplement NumberS009
Date Received11/22/1995
Decision Date12/26/1995
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE
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