PMA P030044S006
- Device
- EGFR pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S006
- Product code
- NQF
- Decision date
- 2019-01-17
- Classification
- Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Approval order statement
- Implementation of an in-process QC specification.
Current openFDA PMA Record#
- Device
- EGFR pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P030044
- Supplement
- S006
- Product code
- NQF
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Decision date
- 2019-01-17
- Decision code
- OK30
- Date received
- 2018-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an in-process QC specification.