MMR IHC Panel pharmDx (Dako Omnis)
FDA premarket approval P250004 · decided 2025-08-15
Approval details
- PMA number
- P250004
- Trade name
- MMR IHC Panel pharmDx (Dako Omnis)
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2025-02-18
- Decision date
- 2025-08-15
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carpinteria, CA
- Statement
- For In Vitro Diagnostic Use.MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Da
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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 |