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

Agilent Technologies, Inc: FDA-registered device maker in Santa Clara, CA, United States, 7 510(k) clearances and 5 PMA approvals

Agilent Technologies, Inc is registered with the FDA (registration 2916205) in Santa Clara, CA, United States. It lists 40 device types. The FDA files 7 510(k) clearances and 5 PMA approvals under its listings, the newest dated August 15, 2025. 4 recall events name it as the recalling firm. 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
2916205
Address
5301 Stevens Creek Blvd, Santa Clara, CA, United States, 95051
Owner or operator
Agilent Technologies, Inc (10038794)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
November 14, 2011
Registered through
2026
Brand names listed
1260 Infinity II LC System Clinical Edition, 28S rRNA CISH Probe, 405LSHT-SI, 405LSHTV-SI, 405LSR-SI, 405LSRS-SI, 405LSRSQ-SI, 405LSRV-SI and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, FuchsinIDF1Specification developeraccessdata.fda.gov
Alcian BlueIDA1Specification developeraccessdata.fda.gov
Ammoniacal Silver Hydroxide Silver NitrateICZ1Specification developeraccessdata.fda.gov
Aniline BlueKFD1Specification developeraccessdata.fda.gov
Apparatus, High Pressure Liquid ChromatographyKIE1Complaint file establishment, Manufactureraccessdata.fda.gov
Bath, Incubators/Water, AllJTQ1Specification developeraccessdata.fda.gov
Carbol FuchsinICL1Specification developeraccessdata.fda.gov
Cells, Animal And Human, CulturedKIR1Specification developeraccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Specification developeraccessdata.fda.gov
Congo RedICH1Specification developeraccessdata.fda.gov
Crystal Violet For HistologyICF1Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Specification developeraccessdata.fda.gov
Giemsa StainHYF1Specification developeraccessdata.fda.gov
HematoxylinHYJ1Specification developeraccessdata.fda.gov
Hematoxylin Mayer'SHYL1Specification developeraccessdata.fda.gov
Immunohistochemistry Antibody Assay, Estrogen ReceptorMYA2Specification developeraccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Ki-67QQT3Specification developeraccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4SBL3Specification developeraccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Progesterone ReceptorMXZ2Specification developeraccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1PLS3Specification developeraccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Specification developeraccessdata.fda.gov
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein AssayQNH3Specification developeraccessdata.fda.gov
Iron StainsGGH1Specification developeraccessdata.fda.gov
Light GreenHYS1Specification developeraccessdata.fda.gov
Mass Spectrometer, Clinical UseDOP1Specification developeraccessdata.fda.gov
Methenamine SilverHYZ1Specification developeraccessdata.fda.gov
Methyl GreenHZA1Specification developeraccessdata.fda.gov
Microscope, Fluorescence/U.V.IBK1Specification developeraccessdata.fda.gov
MucicarmineHZC1Specification developeraccessdata.fda.gov
Muller'S Colloidal IronHZD1Specification developeraccessdata.fda.gov
Nuclear Fast RedHZF1Specification developeraccessdata.fda.gov
OrceinKKF1Specification developeraccessdata.fda.gov
Peroxidase Anti-Peroxidase Immunohistochemical StainLIJ1Specification developeraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Specification developeraccessdata.fda.gov
Reagent, SchiffHZT1Specification developeraccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Specification developeraccessdata.fda.gov
Silver NitrateHZX1Specification developeraccessdata.fda.gov
Slide Stainer, AutomatedKPA1Specification developeraccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Specification developeraccessdata.fda.gov
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality DetectionPFX2Manufacturer, Specification developeraccessdata.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
February 28, 2002K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZSubstantially 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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 20, 202596484Class IIOngoingGenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable geneaccessdata.fda.gov
May 20, 202290435Class IIIOngoingKit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512Label provided for substrate vail contained incorrect expiration date.accessdata.fda.gov
August 15, 201882794Class IITerminatedMassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorWhen utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow accessdata.fda.gov
June 17, 201576698Class IITerminatedBond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - BonThe product was marketed without 510(k) clearance.accessdata.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.