K160512 is an FDA 510(k) clearance for the HardyCHROM ESBL. This device is classified as a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II - Special Controls, product code JSO).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on November 15, 2016, 265 days after receiving the submission on February 24, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1700.
| 510(k) Number | K160512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2016 |
| Decision Date | November 15, 2016 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1700 |