Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
FDA premarket approval P210026/S002 · decided 2025-02-28
Approval details
- PMA number
- P210026
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
- Generic name
- Immunohistochemistry assay, antibody, Ki-67
- Applicant
- Agilent Technologies, Inc.
- Date received
- 2025-01-31
- Decision date
- 2025-02-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QQT
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.
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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 |