The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Fecal Staining Kit.
| Device ID | K810875 |
| 510k Number | K810875 |
| Device Name: | FECAL STAINING KIT |
| Classification | Sudan Iii |
| Applicant | JAYCO PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KKJ |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-31 |
| Decision Date | 1981-05-01 |