The following data is part of a premarket notification filed by Surgipath with the FDA for Harris Hematoxylin.
| Device ID | K810733 |
| 510k Number | K810733 |
| Device Name: | HARRIS HEMATOXYLIN |
| Classification | Hematoxylin Harris's |
| Applicant | SURGIPATH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HYK |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-18 |
| Decision Date | 1981-04-14 |