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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 ANTI-DELTA (EIA) ASSAY
Generic NameHEPATITIS DELTA SEROLOGICAL REAGENTS
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP850062
Supplement NumberS003
Date Received10/03/2001
Decision Date09/05/2002
Withdrawal Date03/22/2007
Product Code LQI 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE ABBOTT ANTI-DELTA (EIA) MASTER LOT TESTING.
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