The following data is part of a premarket notification filed by Shandon, Inc. with the FDA for Instant Hematoxylin.
| Device ID | K873107 |
| 510k Number | K873107 |
| Device Name: | INSTANT HEMATOXYLIN |
| Classification | Hematoxylin Harris's |
| Applicant | SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
| Contact | Janet N Crookham,ba |
| Correspondent | Janet N Crookham,ba SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
| Product Code | HYK |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-07 |
| Decision Date | 1987-08-21 |