AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
FDA 510(k) clearance K011093 · decided 2001-05-01
Clearance details
- K-number
- K011093
- Device name
- AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
- Applicant
- Agilent Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-10
- Decision date
- 2001-05-01
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Viridia/Agilent Information Center Model : M3150A#C01 recall (Z-0594-03) | Philips Medical Systems, Inc. Cardiac & Monitoring Systems | 2003-02-28 |
| Viridia/Agilent Information Center Model : M3151A#CO1 recall (Z-0595-03) | Philips Medical Systems, Inc. Cardiac & Monitoring Systems | 2003-02-28 |
| Intellivue Information Center Model: M3150B#C01 recall (Z-0596-03) | Philips Medical Systems, Inc. Cardiac & Monitoring Systems | 2003-02-28 |
| Intellivue Information Center Model: M3150BU#CO1 recall (Z-0597-03) | Philips Medical Systems, Inc. Cardiac & Monitoring Systems | 2003-02-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MMR IHC Panel pharmDx (Dako Omnis) (P250004) | Agilent Technologies, Inc. | 2025-08-15 |
| PD-L1 IHC 22C3 pharmDx (Dako Omnis) (P150013/S028) | Agilent Technologies, Inc. | 2025-08-04 |
| PD-L1 IHC 28-8 pharmDx (P150025/S017) | Agilent Technologies, Inc. | 2025-06-27 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S002) | Agilent Technologies, Inc. | 2025-06-27 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S030) | Agilent Technologies, Inc. | 2025-06-27 |
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002) | Agilent Technologies, Inc. | 2025-02-28 |
| PD-L1 IHC 22C3 pharmDx (P150013/S029) | Agilent Technologies, Inc. | 2025-02-28 |
| MAGE-A4 IHC 1F9 pharmDx (P230016/S001) | Agilent Technologies, Inc. | 2025-02-28 |