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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 IMX AFP ADDITIONAL PURIFICATION STEP
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 NumberS006
Date Received06/08/1992
Decision Date07/01/1993
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
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