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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) REBBIT 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 NumberS003
Date Received06/26/2012
Decision Date07/24/2012
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of a supplier of raw materials for the iview detection kit, which is part of the device.
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