K170127 is an FDA 510(k) clearance for the HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40. 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 March 14, 2017, 60 days after receiving the submission on January 13, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K170127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2017 |
| Decision Date | March 14, 2017 |
| Days to Decision | 60 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 |