The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Brilliant Green Bile 2%.
| Device ID | K791592 |
| 510k Number | K791592 |
| Device Name: | BRILLIANT GREEN BILE 2% |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | ISLE MEDIA AND STERILE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-14 |
| Decision Date | 1979-09-17 |