PD-L1 IHC 28-8 PHARMDX
FDA premarket approval P150027/S003 · decided 2017-02-24
Approval details
- PMA number
- P150027
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PD-L1 IHC 28-8 PHARMDX
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Applicant
- Dako North America, Inc.
- Date received
- 2016-08-29
- Decision date
- 2017-02-24
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- PLS
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carpinteria, CA
- Statement
- Approval for the updated product labeling and associated data.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (K160922) | Dako North America, Inc. | 2016-05-03 |
| MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) (K130861) | Dako North America, Inc. | 2013-12-09 |
| MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (K120663) | Dako North America, Inc. | 2013-02-12 |
| MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 (K081286) | Dako North America, Inc. | 2009-05-08 |