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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.
 
DeviceHA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP890014
Supplement NumberS003
Date Received10/05/2000
Decision Date02/02/2001
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE STORAGE CONDITIONS AND PURIFICATION PROCESS OF SOME COMPONENTS OF THE HA-IGMK RIA DEVICE, AND THE ETI-HA-IGMK PLUS DEVICE.
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