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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.
 
DeviceIGG ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Generic Nameassay,enzyme linked immunosorbent,parvovirus b19 igg
Applicant
DIASORIN
1951 northwestern avenue
stillwater, MN 55082-0285
PMA NumberP970054
Supplement NumberS004
Date Received05/14/2007
Decision Date06/08/2007
Product Code
MYL[ Registered Establishments with MYL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN A QUALITY CONTROL TEST FOR THE IN-PROCESS DEVICE.
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