PD-L1 IHC 28-8 pharmDx
FDA premarket approval P150025 · decided 2015-10-09
Approval details
- PMA number
- P150025
- Trade name
- PD-L1 IHC 28-8 pharmDx
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2015-07-09
- Decision date
- 2015-10-09
- Days to decision
- 92 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:1) PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTO-CHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48; 2) PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING P
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GenetiSure Dx Postnatal Assay (K163367) | Agilent Technologies, Inc. | 2017-08-11 |
| MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (K012094) | Agilent Technologies, Inc. | 2001-07-20 |
| AGILENT M2636B TELEMON B MONITOR (TELEMON B) (K011824) | Agilent Technologies, Inc. | 2001-07-02 |
| HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B (K010634) | Agilent Technologies, Inc. | 2001-06-11 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K011578) | Agilent Technologies, Inc. | 2001-06-08 |
| HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (K003819) | Agilent Technologies, Inc. | 2001-05-02 |
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093) | Agilent Technologies, Inc. | 2001-05-01 |
| M2376A DEVICELINK SYSTEM (K010453) | Agilent Technologies, Inc. | 2001-03-02 |