Data / Medical devices / Germany / Orgentec Diagnostika GMBH
Orgentec Diagnostika GMBH: FDA-registered device maker in MAINZ Rhineland-Palatinate, Germany, 1 510(k) clearance
Orgentec Diagnostika GMBH is registered with the FDA (registration 3003232042) in MAINZ Rhineland-Palatinate, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003232042
- Address
- Carl-Zeiss-Strasse 49-51, MAINZ Rhineland-Palatinate, Germany, 55129
- Owner or operator
- Corgenix Inc. (9022938)
- Roles
- Manufacturer
- First device listed
- December 23, 2010
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anti-Mutated Citrullinated Vimentin Igg | OQZ | 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 |
|---|---|---|---|---|---|---|
| July 1, 2010 | K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | OQZ | Substantially Equivalent | Orgentec Diagnostika GmbH | accessdata.fda.gov |
Updated July 1, 2010. 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.