The following data is part of a premarket notification filed by Surgipath with the FDA for Eosin Y.
| Device ID | K811826 |
| 510k Number | K811826 |
| Device Name: | EOSIN Y |
| Classification | Eosin Y |
| Applicant | SURGIPATH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HYB |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-29 |
| Decision Date | 1981-07-10 |