DAKO EGFR PHARMDX KIT
FDA premarket approval P030044/S002 · decided 2006-09-27
Approval details
- PMA number
- P030044
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DAKO EGFR PHARMDX KIT
- Generic name
- Immunohistochemistry assay, antibody, epidermal growth factor receptor
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2006-04-03
- Decision date
- 2006-09-27
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NQF
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR ADDING A NEW THERAPY VECTIBIX (PANITUMUMAB) TO INTENDED USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DAKO EGFR PHARMDX KIT AND IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLATIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATIN. EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS. EGFR PHARMDX IS IND
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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 |