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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 NamePATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Nameimmunohistochemistry antibody assay, c-kit
Generic Namerabbit polyclonal antibody for aid in the detection of c-kit antigen in histological tissue section
Regulation Number864.1860
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP020055
Supplement NumberS015
Date Received06/16/2014
Decision Date02/19/2015
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of sanmina built nozzle plate assembly in the manufacture of benchmark xt instrument used in the tests.
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