FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
K Number: K212849
·
Decision Feb 4, 2022
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
288
Applicant Total
1
Review Days
150
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Basic Information
- Device Name
- VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
- K Number
- K212849
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomérieux, Inc.
- Date Received
- September 7, 2021
- Decision Date
- February 4, 2022
- 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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