The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Brain Heart Infusion Agar.
| Device ID | K791630 |
| 510k Number | K791630 |
| Device Name: | BRAIN HEART INFUSION AGAR |
| Classification | Culture Media, Non-selective And Non-differential |
| Applicant | ISLE MEDIA AND STERILE PRODUCTS, INC. 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 | 1979-08-21 |
| Decision Date | 1979-09-27 |