Data / Medical devices / United States / Agilent Technologies, Inc.
Agilent Technologies, Inc.: FDA-registered device maker in Carpinteria, CA, United States, 6 510(k) clearances and 5 PMA approvals
Agilent Technologies, Inc. is registered with the FDA (registration 2022180) in Carpinteria, CA, United States. It lists 33 device types. The FDA files 6 510(k) clearances and 5 PMA approvals under its listings, the newest dated August 15, 2025. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2022180
- Address
- 6392 Via Real, Carpinteria, CA, United States, 93013
- Owner or operator
- Agilent Technologies, Inc (10038794)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 25, 2014
- Registered through
- 2026
- Brand names listed
- 28S rRNA CISH Probe, ADVANCE HRP, AEC Substrate-Chromogen, Ready-to-Use, AEC+ High Sensitivity Substrate Chromogen, Ready-to-Use, AEC+ Substrate-Chromogen, Ready-to-Use, ALK FISH DNA Probe, Split Signal, Anti-FITC-AP CISH Accessory Kit, Antibody Diluent and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2017 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | MYA | Substantially Equivalent | Dako Denmark A/S | accessdata.fda.gov |
| December 21, 2017 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | MXZ | Substantially Equivalent | Dako Denmark A/S | accessdata.fda.gov |
| December 9, 2013 | K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | MXZ | Substantially Equivalent | Dako North America, Inc. | accessdata.fda.gov |
| February 12, 2013 | K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | MYA | Substantially Equivalent | Dako North America, Inc. | accessdata.fda.gov |
| February 15, 2005 | K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | MXZ | Substantially Equivalent | Dakocytomation California, Inc. | accessdata.fda.gov |
| February 28, 2002 | K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | MXZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | P250004 | MMR IHC Panel pharmDx (Dako Omnis) | QNH | 1 | September 11, 2026 | accessdata.fda.gov |
| August 1, 2024 | P230016 | MAGE-A4 IHC 1F9 pharmDx | SBL | 5 | September 21, 2026 | accessdata.fda.gov |
| October 12, 2021 | P210026 | Ki-67 IHC pharmDx | QQT | 3 | September 11, 2026 | accessdata.fda.gov |
| October 9, 2015 | P150025 | PD-L1 IHC 28-8 pharmDx | 18 | September 21, 2026 | accessdata.fda.gov | |
| October 2, 2015 | P150013 | PD-L1 IHC 22C3 PHARMDX | PLS | 35 | September 21, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 2, 2018 | 79602 | Class II | Terminated | PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options. | To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months. | accessdata.fda.gov |
| June 10, 2016 | 74408 | Class II | Terminated | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hyb | An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low. | accessdata.fda.gov |
| September 4, 2015 | 72097 | Class II | Terminated | EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-co | There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results. | accessdata.fda.gov |
| April 1, 2015 | 70898 | Class II | Terminated | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts i | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display the updated test with the requested change, but the Omnis system will execute the initial test, not reflecting the change. The system will not warn the user that the test request wa | accessdata.fda.gov |
| February 12, 2015 | 70558 | Class II | Terminated | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. | A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014. | accessdata.fda.gov |
| August 29, 2014 | 69191 | Class II | Terminated | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents fo | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely | accessdata.fda.gov |
| January 21, 2014 | 67380 | Class II | Terminated | Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved wit | Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. | accessdata.fda.gov |
| May 1, 2008 | 53336 | Class II | Terminated | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. | Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open. | accessdata.fda.gov |
| October 14, 2005 | 33957 | Not yet classified | Terminated | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000 | This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. | accessdata.fda.gov |
| September 29, 2005 | 33707 | Not yet classified | Terminated | K 520411-2, Hercep Test, 35Test, HER2, Protein | Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation. | accessdata.fda.gov |
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Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.