Data / Medical devices / Denmark / Agilent Technologies Denmark ApS
Agilent Technologies Denmark ApS: FDA-registered device maker in GLOSTRUP Hovedstaden, Denmark, 28 510(k) clearances and 2 PMA approvals
Agilent Technologies Denmark ApS is registered with the FDA (registration 9610099) in GLOSTRUP Hovedstaden, Denmark. It lists 41 device types. The FDA files 28 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 21, 2017. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610099
- FEI number
- 3002806778
- Address
- 42 Produktionsvej, GLOSTRUP Hovedstaden, Denmark, DK-2600
- Owner or operator
- Agilent Technologies, Inc (10038794)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 25, 2014
- Registered through
- 2026
- Brand names listed
- 28S rRNA CISH Probe, ACIS III Tissue Micro-Array Application Software, 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, ARK (Animal Research Kit)/HRP 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 | 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 |
| September 3, 2004 | K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | NDY | Substantially Equivalent | Dako A/S | accessdata.fda.gov |
| January 22, 2004 | K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | JZG | Substantially Equivalent | Dako A/S | accessdata.fda.gov |
| June 21, 1999 | K991454 | MOUSE IGG1 NEGATIVE CONTROLS | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| June 21, 1999 | K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 22, 1998 | K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| June 24, 1997 | K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| June 14, 1996 | K960531 | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| May 17, 1996 | K960887 | MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| January 26, 1996 | K945212 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| April 20, 1995 | K931192 | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY | DEH | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| November 21, 1994 | K944253 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| November 21, 1994 | K943284 | MONOCLONAL MOUSE ANTI-HUMAN B-CELL | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| November 10, 1994 | K942797 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL | GKZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 19, 1983 | K831907 | RABBIT ANTISERUM TO HUMAN IGM | DFS | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 19, 1983 | K831906 | RABBIT ANTISERUM TO HUMAN C4 | DBI | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 19, 1983 | K831904 | RABBIT ANTISERUM TO HUMAN KAPPA LIGHT | DEO | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 19, 1983 | K831903 | FLUORESCEIN CONJUGATED IMMUNOGLOBULIN | DES | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 18, 1983 | K831909 | RABBIT ANTISERUM TO HUMAN IGA | CZN | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 18, 1983 | K831908 | RABBIT ANTISERUM TO HUMAN IGG | DGK | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 18, 1983 | K831905 | RABBITT ANTISERUM TO HUMAN C3C | CZW | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| July 18, 1983 | K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | DDZ | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 29, 1981 | K812662 | IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA | DEH | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 29, 1981 | K812661 | IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA | DFH | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 23, 1981 | K812495 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA | DEW | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 23, 1981 | K812489 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG | DEW | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 23, 1981 | K812488 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA | CZP | Substantially Equivalent | Dako Corp. | accessdata.fda.gov |
| September 23, 1981 | K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | DAO | 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 |
|---|---|---|---|---|---|---|
| May 3, 2005 | P040005 | DAKOCYTOMATION HER2 FISH PHARMDX KIT | MVD | 14 | April 12, 2017 | accessdata.fda.gov |
| September 25, 1998 | P980018 | DAKO HERCEPTEST | MVC | 27 | 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 |
|---|---|---|---|---|---|---|
| August 11, 2025 | 97421 | Class II | Ongoing | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clo | Their is the potential for weak staining which may result in false negative CD20 identification. | accessdata.fda.gov |
| November 5, 2019 | 84465 | Class II | Terminated | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800. | The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining. | accessdata.fda.gov |
| July 6, 2016 | 74608 | Class II | Terminated | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments. | The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. | accessdata.fda.gov |
| November 26, 2012 | 63807 | Class II | Terminated | CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slid | The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. | accessdata.fda.gov |
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Updated September 15, 2025. 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.