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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 NumberS002
Date Received11/27/2012
Decision Date12/26/2012
Product Code
OWE[ Registered Establishments with OWE ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Qualify the geneprep instrument, qualify the overhead mixing system and validate the mixing process in the manufacture of the hybridization buffer, and transfer an existing in-process testing of labeled dna.
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