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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 NumberS001
Date Received12/19/2011
Decision Date06/07/2012
Product Code
OWE[ Registered Establishments with OWE ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of an alternate supplier for the human placental (hp) dna component for the device, per design verification protocol md17892.
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