PMA P040011
- Device
- C-Kit pharmDx
- Applicant
- Dako North America, Inc.
- PMA number
- P040011
- Supplement
- S003
- Product code
- NKF
- Decision date
- 2017-05-16
- Classification
- Immunohistochemistry Antibody Assay, C-kit
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- Changes to the relocation/ expansion of facility.
Current openFDA PMA Record#
- Device
- C-Kit pharmDx
- Applicant
- Dako North America, Inc.
- PMA number
- P040011
- Supplement
- S003
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2017-05-16
- Decision code
- OK30
- Date received
- 2017-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the relocation/ expansion of facility.