- Device
- PD-L1 IHC 22C3 PharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P150013
- Supplement
- S019
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2020-11-06
- Decision code
- APPR
- Date received
- 2020-02-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Dako Denmark ApS, Produktionsvej 42, DK-2600 Glostrup, Denmark for device manufacturing.