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Data / Medical devices / United States / Agilent Technologies Inc.

Agilent Technologies Inc.: FDA-registered device maker in Cedar Creek, TX, United States, 34 510(k) clearances and 7 PMA approvals

Agilent Technologies Inc. is registered with the FDA (registration 3009189893) in Cedar Creek, TX, United States. It lists 70 device types. The FDA files 34 510(k) clearances and 7 PMA approvals under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Agilent Technologies Inc.
FDA registration number
3009189893
Address
1834 State Highway 71 West, Cedar Creek, TX, United States, 78612
Owner or operator
Agilent Technologies, Inc (10038794)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
November 22, 2011
Registered through
2026
Brand names listed
28S rRNA CISH Probe, 4150 TapeStationDx Instrument, 4200 TapeStationDx Instrument, 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 and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, FuchsinIDF1Complaint file establishmentaccessdata.fda.gov
Agent, ClearingKEM1Complaint file establishmentaccessdata.fda.gov
Albumin, Fitc, Antigen, Antiserum, ControlDDZ2Complaint file establishmentaccessdata.fda.gov
Alcian BlueIDA1Complaint file establishmentaccessdata.fda.gov
Ammoniacal Silver Hydroxide Silver NitrateICZ1Complaint file establishmentaccessdata.fda.gov
Aniline BlueKFD1Complaint file establishmentaccessdata.fda.gov
Apparatus, Electrophoresis, For Clinical UseJJN1Complaint file establishmentaccessdata.fda.gov
Calibrator, SecondaryJIT2Complaint file establishmentaccessdata.fda.gov
Carbol FuchsinICL1Complaint file establishmentaccessdata.fda.gov
Cells, Animal And Human, CulturedKIR1Complaint file establishmentaccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Complaint file establishmentaccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Complaint file establishmentaccessdata.fda.gov
Congo RedICH1Complaint file establishmentaccessdata.fda.gov
Counter, Differential CellGKZ2Complaint file establishmentaccessdata.fda.gov
Coverslips, Microscope SlideKES1Complaint file establishmentaccessdata.fda.gov
Crystal Violet For HistologyICF1Complaint file establishmentaccessdata.fda.gov
Eosin YHYB1Complaint file establishmentaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishmentaccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishment, Manufactureraccessdata.fda.gov
Giemsa StainHYF1Complaint file establishmentaccessdata.fda.gov
HematoxylinHYJ1Complaint file establishmentaccessdata.fda.gov
Hematoxylin Mayer'SHYL1Complaint file establishmentaccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Complaint file establishmentaccessdata.fda.gov
Iga, Fitc, Antigen, Antiserum, ControlCZN2Complaint file establishmentaccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Complaint file establishmentaccessdata.fda.gov
Igg, Fitc, Antigen, Antiserum, ControlDGK2Complaint file establishmentaccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Complaint file establishmentaccessdata.fda.gov
Igm, Fitc, Antigen, Antiserum, ControlDFS2Complaint file establishmentaccessdata.fda.gov
Immunochemical, Lysozyme (Muramidase)JMR1Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Antibody Assay, Estrogen ReceptorMYA2Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Ki-67QQT3Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4SBL3Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Progesterone ReceptorMXZ2Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1PLS3Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Complaint file establishmentaccessdata.fda.gov
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein AssayQNH3Complaint file establishmentaccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Complaint file establishmentaccessdata.fda.gov
Iron StainsGGH1Complaint file establishmentaccessdata.fda.gov
Kappa, Antigen, Antiserum, ControlDFH2Complaint file establishmentaccessdata.fda.gov
Kappa, Fitc, Antigen, Antiserum, ControlDEO2Complaint file establishmentaccessdata.fda.gov
Lambda, Antigen, Antiserum, ControlDEH2Complaint file establishmentaccessdata.fda.gov
Lambda, Fitc, Antigen, Antiserum, ControlDES2Complaint file establishmentaccessdata.fda.gov
Light GreenHYS1Complaint file establishmentaccessdata.fda.gov
Mass Spectrometer, Clinical UseDOP1Complaint file establishmentaccessdata.fda.gov
Medical Device Data SystemOUG1Complaint file establishmentaccessdata.fda.gov
Methenamine SilverHYZ1Complaint file establishmentaccessdata.fda.gov
Methyl GreenHZA1Complaint file establishmentaccessdata.fda.gov
Mounting MediaLEB1Complaint file establishmentaccessdata.fda.gov
MucicarmineHZC1Complaint file establishmentaccessdata.fda.gov
Muller'S Colloidal IronHZD1Complaint file establishmentaccessdata.fda.gov
Nuclear Fast RedHZF1Complaint file establishmentaccessdata.fda.gov
OrceinKKF1Complaint file establishmentaccessdata.fda.gov
Peroxidase Anti-Peroxidase Immunohistochemical StainLIJ1Complaint file establishmentaccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Complaint file establishmentaccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Complaint file establishmentaccessdata.fda.gov
Reagent, SchiffHZT1Complaint file establishmentaccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Complaint file establishment, Manufactureraccessdata.fda.gov
Research Use Only/PathologyOTUNComplaint file establishmentaccessdata.fda.gov
Retinol-Binding Protein, Antigen, Antiserum, ControlCZS1Complaint file establishmentaccessdata.fda.gov
Silver NitrateHZX1Complaint file establishmentaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Complaint file establishmentaccessdata.fda.gov
Slide Stainer, AutomatedKPA1Complaint file establishmentaccessdata.fda.gov
Slides, MicroscopeKEW1Complaint file establishmentaccessdata.fda.gov
Stains, Dye SolutionLEE1Complaint file establishmentaccessdata.fda.gov
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionPFX2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Complaint file establishmentaccessdata.fda.gov
System, Test, Her-2/Neu, IhcMVC3Complaint file establishmentaccessdata.fda.gov
System, Test, Her-2/Neu, Nucleic Acid Or SerumMVD2Complaint file establishmentaccessdata.fda.gov
Test, Cystatin CNDY2Complaint file establishmentaccessdata.fda.gov
Whole Human Serum, Antigen, Antiserum, ControlDGR1Complaint file establishmentaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 21, 2017K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYASubstantially EquivalentDako Denmark A/Saccessdata.fda.gov
December 21, 2017K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZSubstantially EquivalentDako Denmark A/Saccessdata.fda.gov
August 11, 2017K163367GenetiSure Dx Postnatal AssayPFXSubstantially EquivalentAgilent Technologies, Inc.accessdata.fda.gov
December 9, 2013K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZSubstantially EquivalentDako North America, Inc.accessdata.fda.gov
February 12, 2013K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYASubstantially EquivalentDako North America, Inc.accessdata.fda.gov
February 15, 2005K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZSubstantially EquivalentDakocytomation California, Inc.accessdata.fda.gov
September 3, 2004K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDYSubstantially EquivalentDako A/Saccessdata.fda.gov
January 22, 2004K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZGSubstantially EquivalentDako A/Saccessdata.fda.gov
February 28, 2002K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZSubstantially EquivalentDako Corp.accessdata.fda.gov
June 21, 1999K991454MOUSE IGG1 NEGATIVE CONTROLSGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
June 21, 1999K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZSubstantially EquivalentDako Corp.accessdata.fda.gov
July 22, 1998K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZSubstantially EquivalentDako Corp.accessdata.fda.gov
June 24, 1997K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
June 14, 1996K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
May 17, 1996K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
January 26, 1996K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZSubstantially EquivalentDako Corp.accessdata.fda.gov
April 20, 1995K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEHSubstantially EquivalentDako Corp.accessdata.fda.gov
November 21, 1994K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZSubstantially EquivalentDako Corp.accessdata.fda.gov
November 21, 1994K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
November 10, 1994K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZSubstantially EquivalentDako Corp.accessdata.fda.gov
July 19, 1983K831907RABBIT ANTISERUM TO HUMAN IGMDFSSubstantially EquivalentDako Corp.accessdata.fda.gov
July 19, 1983K831906RABBIT ANTISERUM TO HUMAN C4DBISubstantially EquivalentDako Corp.accessdata.fda.gov
July 19, 1983K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEOSubstantially EquivalentDako Corp.accessdata.fda.gov
July 19, 1983K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDESSubstantially EquivalentDako Corp.accessdata.fda.gov
July 18, 1983K831909RABBIT ANTISERUM TO HUMAN IGACZNSubstantially EquivalentDako Corp.accessdata.fda.gov
July 18, 1983K831908RABBIT ANTISERUM TO HUMAN IGGDGKSubstantially EquivalentDako Corp.accessdata.fda.gov
July 18, 1983K831905RABBITT ANTISERUM TO HUMAN C3CCZWSubstantially EquivalentDako Corp.accessdata.fda.gov
July 18, 1983K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZSubstantially EquivalentDako Corp.accessdata.fda.gov
September 29, 1981K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEHSubstantially EquivalentDako Corp.accessdata.fda.gov
September 29, 1981K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFHSubstantially EquivalentDako Corp.accessdata.fda.gov
September 23, 1981K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEWSubstantially EquivalentDako Corp.accessdata.fda.gov
September 23, 1981K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEWSubstantially EquivalentDako Corp.accessdata.fda.gov
September 23, 1981K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZPSubstantially EquivalentDako Corp.accessdata.fda.gov
September 23, 1981K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAOSubstantially EquivalentDako Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 15, 2025P250004MMR IHC Panel pharmDx (Dako Omnis)QNH1September 11, 2026accessdata.fda.gov
August 1, 2024P230016MAGE-A4 IHC 1F9 pharmDxSBL5September 21, 2026accessdata.fda.gov
October 12, 2021P210026Ki-67 IHC pharmDxQQT3September 11, 2026accessdata.fda.gov
October 9, 2015P150025PD-L1 IHC 28-8 pharmDx18September 21, 2026accessdata.fda.gov
October 2, 2015P150013PD-L1 IHC 22C3 PHARMDXPLS35September 21, 2026accessdata.fda.gov
May 3, 2005P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD14April 12, 2017accessdata.fda.gov
September 25, 1998P980018DAKO HERCEPTESTMVC27September 21, 2026accessdata.fda.gov

Compare with other makers

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.