Data / Medical devices / United Kingdom / Sercon Limited
Sercon Limited: FDA-registered device maker in crewe Cheshire East, United Kingdom, 1 510(k) clearance
Sercon Limited is registered with the FDA (registration 3007386004) in crewe Cheshire East, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 13, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007386004
- Address
- Europa House, Coppicemere Drive, crewe Cheshire East, United Kingdom, CW1 6GZ
- Owner or operator
- Sercon Ltd (10039112)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 9, 2011
- Registered through
- 2026
- Brand names listed
- Sercon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mass Spectrometer, Clinical Use | DOP | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 13, 1999 | K992163 | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | DOP | Substantially Equivalent | Pdz-Europa , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 13, 1999. 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.