The following data is part of a premarket notification filed by Harleco with the FDA for Hemocolor Stain Set.
| Device ID | K810684 |
| 510k Number | K810684 |
| Device Name: | HEMOCOLOR STAIN SET |
| Classification | Eosin B |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ICC |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-13 |
| Decision Date | 1981-04-08 |