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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 HAVAB -M EIA
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49C, BUILDING AP6C
100 ABBOTT PARK ROAD
ABBOTT PARK NORTH, IL 60064-3500
PMA NumberP790019
Supplement NumberS019
Date Received04/25/2005
Decision Date05/25/2005
Reclassified Date 02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ABBOTT HAVAB -M EIA ASSAY.
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