The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardychrom Esbl.
| Device ID | K160512 |
| 510k Number | K160512 |
| Device Name: | HardyCHROM ESBL |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOU LANE Santa Maria, CA 93455 |
| Contact | Andre Hsiung |
| Correspondent | Andre Hsiung HARDY DIAGNOSTICS 1430 WEST MCCOU LANE Santa Maria, CA 93455 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576023097 | K160512 | 000 |
| 00816576026838 | K160512 | 000 |