FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K Number: K260447
·
Decision Apr 21, 2026
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
1
Review Days
69
Basic Information
- Device Name
- ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- K Number
- K260447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMérieux SA
- Date Received
- February 11, 2026
- Decision Date
- April 21, 2026
- Product Code
- JWY
- 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | FDA class 2 | Microbiology |
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