The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Harris Hematoxylin.
| Device ID | K872498 |
| 510k Number | K872498 |
| Device Name: | HARRIS HEMATOXYLIN |
| Classification | Hematoxylin Harris's |
| Applicant | ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
| Contact | Ada T Feldman |
| Correspondent | Ada T Feldman ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
| Product Code | HYK |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-24 |
| Decision Date | 1987-07-09 |