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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 NameVYSIS ALK BREAK APART FISH PROBE KIT
Classification Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP110012
Supplement NumberS005
Date Received11/05/2013
Decision Date11/27/2013
Product Code
OWE[ Registered Establishments with OWE ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changing the configuration of their current label printer, label printing software, and label inspection system for the following fish assays: vysis alk break apart fish probe kit, urovysion bladder cancer kit, and pathvysion her-2dna probe kit.
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