Agilent Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 45
- Inspections
- 15
- Compliance Actions
- 0
Known Names
agilent technologies, agilent technologies denmark aps, agilent technologies singapore (international)
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1544-2025 | Class II | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7 | March 20, 2025 |
| Z-1919-2024 | Class II | Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO | April 2, 2024 |
| Z-1384-2022 | Class III | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Acc | May 20, 2022 |
| Z-2359-2019 | Class II | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectro | August 15, 2018 |
| Z-1737-2017 | Class II | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card | June 17, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163367 | GenetiSure Dx Postnatal Assay | August 11, 2017 |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | September 28, 2001 |
| K012094 | MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A | July 20, 2001 |
| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | July 2, 2001 |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2 | June 11, 2001 |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | June 8, 2001 |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | May 2, 2001 |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 | May 1, 2001 |
| K010453 | M2376A DEVICELINK SYSTEM | March 2, 2001 |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | February 14, 2001 |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | February 8, 2001 |
| K010048 | M2376A DEVICELINK SYSTEM | February 1, 2001 |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | January 5, 2001 |
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A | December 20, 2000 |
| K003621 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 | December 20, 2000 |
| K003622 | M2376A DEVICELINK SYSTEM, MODEL M2376A | December 18, 2000 |
| K002459 | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH | November 8, 2000 |
| K003107 | M2376A DEVICELINK SYSTEM | October 19, 2000 |
| K002967 | M2376A DEVICELINK SYSTEM, MODEL M2376A | October 18, 2000 |
| K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER | September 8, 2000 |