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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.
 
DeviceDIASORIN 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 NumberS007
Date Received06/03/2005
Decision Date06/22/2005
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE DEVICE.
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