The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Culture Media, Antimicrobial Susceptibility Test.
| Device ID | K951754 |
| 510k Number | K951754 |
| Device Name: | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Melissa M Taylor |
| Correspondent | Melissa M Taylor 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 | 1995-04-17 |
| Decision Date | 1995-10-16 |