Data / Medical devices / Singapore / Agilent Technologies Singapore (International) Pte Ltd.
Agilent Technologies Singapore (International) Pte Ltd.: FDA-registered device maker in Singapore North East, Singapore, 28 510(k) clearances and 2 PMA approvals
Agilent Technologies Singapore (International) Pte Ltd. is registered with the FDA (registration 3003423869) in Singapore North East, Singapore. It lists 45 device types. The FDA files 28 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 21, 2017. 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.
- FDA registration number
- 3003423869
- Address
- Agilent Technologies No.1 Yishun Avenue 7, Singapore North East, Singapore, 768923
- Owner or operator
- Agilent Technologies, Inc (10038794)
- Roles
- Exporter to the US, 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, 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 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 |
Compare with other makers
- All makers of Products, Red-Cell Lysing Products
- All makers of Calibrator, Secondary
- All makers of Test, Cystatin C
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Reagents, Specific, Analyte
- All makers of Complement C4, Antigen, Antiserum, Control
Updated December 21, 2017. 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.