PMA P020055S009
- Device
- PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S009
- Product code
- NKF
- Decision date
- 2013-10-02
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- ADD A SUPPLIER (ROCHE, PENZBERG) OF A COMPONENT (STREPTAVIDIN HORSERADISH PEROXIDASE) FOR THE IVIEW DAB DETECTION KIT.
Current openFDA PMA Record#
- Device
- PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S009
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2013-10-02
- Decision code
- OK30
- Date received
- 2013-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A SUPPLIER (ROCHE, PENZBERG) OF A COMPONENT (STREPTAVIDIN HORSERADISH PEROXIDASE) FOR THE IVIEW DAB DETECTION KIT.