PMA P020055S012
- Device
- PATHWAY ANTI-C-KIT (9.7.) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S012
- Product code
- NKF
- Decision date
- 2013-12-16
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.
Current openFDA PMA Record#
- Device
- PATHWAY ANTI-C-KIT (9.7.) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S012
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2013-12-16
- Decision code
- OK30
- Date received
- 2013-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW SUPPLIER FOR A PCBA USED IN THE MANUFACTURE OF THE BENCHMARK XT INSTRUMENT.