HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)— 510(k) K231568
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K231568 for HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20), Substantially Equivalent on 2023-07-06. Applicant: Hardy Diagnostics.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Code JTN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.