FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
PMA: P150013
·
Supplement: S013
·
Decision Jan 17, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
- Trade Name
- PD-L1 IHC 22C3 pharmDx
- PMA Number
- P150013
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- PLS
- Generic Name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 17, 2019
- Date Received
- December 21, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Implementation of an in-process QC specification.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLS | Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 | FDA class 3 | Unknown |