FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Selux AST System; Model AST Gen 1.0
K Number: K211759
·
Decision Jan 18, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
288
Applicant Total
4
Review Days
590
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Basic Information
- Device Name
- Selux AST System; Model AST Gen 1.0
- K Number
- K211759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Selux Diagnostics, Inc.
- Date Received
- June 7, 2021
- Decision Date
- January 18, 2023
- 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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