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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) RABBITT MONOCLONAL PRIMARY ANTOBODY
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 NumberS010
Date Received12/18/2013
Decision Date06/13/2014
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of a new supplier for production of the bulk raw material and for a design change where the unpurified cell culture medium diluting the bulk raw material will switch from an rpmi-based solution to an e-rdf 5-based solution.
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