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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIGM ENZYME IMMUNOASSAY
Classification Nameassay,enzyme linked immunosorbent,parvovirus b19 igm
ApplicantBIOTRIN TECHNOLOGIES
PMA NumberP970055
Supplement NumberS004
Date Received05/14/2007
Decision Date06/08/2007
Product Code
MYM[ Registered Establishments with MYM ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
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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