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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.
 
DeviceETI-HA-IGMK PLUS KIT
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantDiaSorin, Inc.
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP890014
Supplement NumberS008
Date Received07/20/2005
Decision Date12/14/2005
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGE TO THE ASSAY CUTOFF CALCULATION THAT IS DESIGNED TO REDUCE THE NUMBER OF LOW LEVEL, NON-CLINICALLY RELEVANT POSITIVE RESULTS REPORTED BY THE ETI-HA-IGMK PLUS ASSAY.
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