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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 NamePATHVYSION HER-2 DNA PROBE KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP980024
Supplement NumberS004
Date Received12/22/2010
Decision Date01/10/2011
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Process change to the manufacture of the fish dna bulk probe solution to increase the batch range up to 2000 ml.
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