K191931 is an FDA 510(k) clearance for the HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25). 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 31, 2019, 12 days after receiving the submission on July 19, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K191931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 12 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 |