Data / Medical devices / United States / Oxford Gene Technology, Inc.
Oxford Gene Technology, Inc.: FDA-registered device maker in North Tarrytown, NY, United States, 2 510(k) clearances
Oxford Gene Technology, Inc. is registered with the FDA (registration 3011279282) in North Tarrytown, NY, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011279282
- Address
- 520 White Plains Rd Ste 500, North Tarrytown, NY, United States, 10591
- Owner or operator
- Oxford Gene Technology (IP) Limited (9026291)
- Roles
- Complaint file establishment
- First device listed
- June 14, 2001
- Registered through
- 2026
- Brand names listed
- Analyte Specific Reagents with the following brand names:, CytoCell, CytoCell 20x SSC Buffer (PCA 003), CytoCell 24 Square Template Slides (PCN 007), CytoCell 8 Square Template Slides (PCN 008), CytoCell DAPI Antifade Counterstain ES (DES 500L, DES 1000L, DES 10ML), CytoCell DAPI Antifade Counterstain FS (DFS 500L, DFS 10ML), CytoCell DAPI Antifade Counterstain SS (DSS 500L) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies | QDI | 2 | Complaint file establishment | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Complaint file establishment | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Complaint file establishment | accessdata.fda.gov |
| Revumenib Eligibility Detection System | SFS | 2 | Complaint file establishment | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2025 | DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | SFS | Unknown | Cytocell Limited | accessdata.fda.gov |
| December 21, 2018 | DEN170070 | MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit | QDI | Unknown | Cytocell, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 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.