K231568 is an FDA 510(k) clearance for the HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20). This device is classified as a Susceptibility Test Discs, Antimicrobial (Class II - Special Controls, product code JTN).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on July 6, 2023, 36 days after receiving the submission on May 31, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K231568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2023 |
| Decision Date | July 06, 2023 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTN — Susceptibility Test Discs, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1620 |