Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: C-Kit pharmDx
• Generic Name: Immunohistochemistry antibody assay, c-kit
• Regulation Number: 864.1860
• Applicant: DAKO NORTH AMERICA, INC.; 6392 VIA REAL; CARPINTERIA, CA 93013
• PMA Number: P040011
• Supplement Number: S003
• Date Received: 04/17/2017
• Decision Date: 05/16/2017
• Withdrawal Date: 05/23/2018
• Product Code: NKF
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Changes to the relocation/ expansion of facility.