The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardychrom Cre.
| Device ID | K190553 |
| 510k Number | K190553 |
| Device Name: | HardyCHROM CRE |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Contact | Rianna Malherbe |
| Correspondent | Rianna Malherbe Hardy Diagnostics 1430 West McCoy 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 | 2019-03-05 |
| Decision Date | 2019-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576025770 | K190553 | 000 |