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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 ASSAY
Generic NameKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Regulation Number866.6010
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP820060
Supplement NumberS014
Date Received09/28/2001
Decision Date09/05/2002
Withdrawal Date11/15/2013
Product Code LOJ 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
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