Data / Medical devices / United Kingdom / Helena Laboratories UK Ltd
Helena Laboratories UK Ltd: FDA-registered device maker in Gateshead Newcastle upon Tyne, United Kingdom, 1 510(k) clearance
Helena Laboratories UK Ltd is registered with the FDA (registration 3009736003) in Gateshead Newcastle upon Tyne, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009736003
- Address
- Queensway South Team Valley Trading Estate, Gateshead Newcastle upon Tyne, United Kingdom, NE11 0SD
- Owner or operator
- Helena Biosciences Europe (10041365)
- Roles
- Manufacturer
- First device listed
- July 17, 2012
- Registered through
- 2027
- Brand names listed
- V8 Immunodisplacement Kit, V8 Nexus Electrophoresis Instrument, V8 UltraCE Electrophoresis Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrophoretic, Protein Fractionation | CEF | 1 | Manufacturer | accessdata.fda.gov |
| Immunoelectrophoretic, Immunoglobulins, (G, A, M) | CFF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 26, 2012 | K111369 | THE HELENA V8 IMMUNODISPLACEMENT KIT | CFF | Substantially Equivalent | Helena Laboratories Uk, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrophoretic, Protein Fractionation
- All makers of Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Updated June 26, 2012. 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.