The following data is part of a premarket notification filed by Hardy Media with the FDA for Sabouraud's Dextrose (sabdex).
| Device ID | K821604 |
| 510k Number | K821604 |
| Device Name: | SABOURAUD'S DEXTROSE (SABDEX) |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | HARDY MEDIA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSG |
| CFR Regulation Number | 866.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-28 |
| Decision Date | 1982-07-06 |