FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL
K Number: K172944
·
Decision Dec 19, 2017
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
284
Applicant Total
29
Review Days
84
Basic Information
- Device Name
- VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL
- K Number
- K172944
- 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
- September 26, 2017
- Decision Date
- December 19, 2017
- 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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Colibrí
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