The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardychrom Mrsa.
| Device ID | K102922 |
| 510k Number | K102922 |
| Device Name: | HARDYCHROM MRSA |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Rene Clasen |
| Correspondent | Rene Clasen HARDY DIAGNOSTICS 1430 WEST MCCOY LN. 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 | 2010-10-01 |
| Decision Date | 2011-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576020140 | K102922 | 000 |
| 00816576020096 | K102922 | 000 |