The following data is part of a premarket notification filed by Hardy Media with the FDA for Brain Heart Infusion.
| Device ID | K821597 |
| 510k Number | K821597 |
| Device Name: | BRAIN HEART INFUSION |
| Classification | Culture Media, General Nutrient Broth |
| Applicant | HARDY MEDIA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSC |
| CFR Regulation Number | 866.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-20 |
| Decision Date | 1982-07-08 |