Data / Medical devices / Spain / Biomerieux Spain
Biomerieux Spain: FDA-registered device maker in Tres Cantos Madrid(Province), Spain, 2 510(k) clearances
Biomerieux Spain is registered with the FDA (registration 3009307598) in Tres Cantos Madrid(Province), Spain. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 25, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009307598
- Address
- Isaac Newton, 6, Tres Cantos Madrid(Province), Spain, 28760
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Manufacturer
- First device listed
- August 25, 1992
- Registered through
- 2027
- Brand names listed
- API 20 STREP, API CAMPY, API CORYNE, API LISTERIA, API Mineral Oil, API NACL 0.85%, API NH, API RAPIDEC Staph and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | JSO | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective Broth | JSD | 1 | Manufacturer | accessdata.fda.gov |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Staphylococcus Aureus | JWX | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | 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 |
|---|---|---|---|---|---|---|
| October 25, 2016 | K162076 | chromID MRSA | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 11, 2016 | K151688 | chromID MRSA | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Selective And Differential
- All makers of Culture Media, Selective Broth
- All makers of Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- All makers of Kit, Screening, Urine
- All makers of Discs, Strips And Reagents, Microorganism Differentiation
- All makers of Kit, Screening, Staphylococcus Aureus
Updated October 25, 2016. 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.