FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K Number: K031410
·
Decision Jul 10, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
284
Applicant Total
115
Review Days
66
Basic Information
- Device Name
- VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
- K Number
- K031410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMERIEUX, INC.
- Date Received
- May 5, 2003
- Decision Date
- July 10, 2003
- Product Code
- LON
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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Other Clearances by BIOMERIEUX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) | Feb 16, 2017 | Substantially Equivalent |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | Mar 25, 2016 | Substantially Equivalent |
| K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | Aug 19, 2014 | Substantially Equivalent |
| K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | Aug 5, 2014 | Substantially Equivalent |
| K141149 | VITEK 2 AST GP CEFTAROLINE | Jun 20, 2014 | Substantially Equivalent |
| K132507 | VITEK 2 AST ST MEROPENEM | Nov 15, 2013 | Substantially Equivalent |
| K131779 | VITEK 2 AST-ST TIGECYCLINE | Oct 10, 2013 | Substantially Equivalent |
| K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN | Sep 13, 2013 | Substantially Equivalent |
| DEN130013 | VITEK MS | Aug 21, 2013 | Unknown |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | Jan 25, 2013 | Substantially Equivalent |