Data / Medical devices / United States / Biomerieux, Inc.
Biomerieux, Inc.: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances and 1 PMA approval
Biomerieux, Inc. is registered with the FDA (registration 3025775667) in Salt Lake City, UT, United States. It lists 2 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated January 19, 2007. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3025775667
- Address
- 1201 S 4800 W, Salt Lake City, UT, United States, 84104
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Complaint file establishment
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- VITEK 2 AST-GN Amikacin, VITEK 2 AST-GN Amox/Clav, VITEK 2 AST-GN Amp/Sulbactam, VITEK 2 AST-GN Ampicillin, VITEK 2 AST-GN Aztreonam, VITEK 2 AST-GN Cefalotin, VITEK 2 AST-GN Cefazolin, VITEK 2 AST-GN Cefepime and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Susceptibility Test Cards, Antimicrobial | LTW | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| January 19, 2007 | K063597 | VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 14, 2005 | K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 2, 1978 | N50510 | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | LTW | 130 | October 17, 2001 | accessdata.fda.gov |
Compare with other makers
- All makers of Susceptibility Test Cards, Antimicrobial
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Updated January 19, 2007. 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.