Data / Medical devices / United Kingdom / Cambridge Sensors Limited
Cambridge Sensors Limited: FDA-registered device maker in HUNTINGDON, Cambridgeshire, United Kingdom, 2 510(k) clearances
Cambridge Sensors Limited is registered with the FDA (registration 3004176168) in HUNTINGDON, Cambridgeshire, United Kingdom. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2009. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004176168
- Address
- Units 9&10 Cardinal Park Godmanchester, HUNTINGDON, Cambridgeshire, United Kingdom, PE29 2XG
- Owner or operator
- CAMBRIDGE SENSORS LIMITED (9057881)
- Roles
- Manufacturer
- First device listed
- February 14, 2008
- Registered through
- 2026
- Brand names listed
- Microdot Test Strips, Microdot Xtra Test Strips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| November 19, 2009 | K083273 | MICRODOT XTRA | NBW | Substantially Equivalent | Cambridge Sensors Limited | accessdata.fda.gov |
| June 22, 2007 | K070524 | MICRODOT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Cambridge Sensors Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 26, 2018 | 82867 | Class II | Ongoing | Microdot Xtra blood glucose test strips | The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the inlet port of the BG meter, therefore resulting in a delay in BG testing and results. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Dehydrogenase, Glucose
Updated November 19, 2009. 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.