510(k) clearance
HardyDisk AST Tebipenem 10µg (TBP10)
- 510(k) number
- K262113
- Applicant
- Hardy Diagnostics
- Decision date
- Aug 20, 2026
- Date received
- Jun 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JTN
- Device type
- Susceptibility Test Discs, Antimicrobial
- Device class
- Class II
- Regulation
- 21 CFR 866.1620
- Advisory committee
- Microbiology
- Statement or summary
- Statement
- Third party
- N
- Location
- Santa Maria, CA, US