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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.
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
PMA NumberP020055
Supplement NumberS002
Date Received06/14/2011
Decision Date09/27/2011
Product Code
NKF[ Registered Establishments with NKF ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a strainer type barrier to the current dab dispenser retainer design, colorization of stop barrel, and assembly equipment updates to accommodate the modified retainer.