PMA P020055S017
- Device
- VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S017
- Product code
- NKF
- Decision date
- 2015-09-24
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Approval order statement
- CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.
Current openFDA PMA Record#
- Device
- VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P020055
- Supplement
- S017
- Product code
- NKF
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Decision date
- 2015-09-24
- Decision code
- OK30
- Date received
- 2015-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS.