The following data is part of a premarket notification filed by Tomtec with the FDA for Guamstainer.
| Device ID | K811697 |
| 510k Number | K811697 |
| Device Name: | GUAMSTAINER |
| Classification | Slide Stainer, Automated |
| Applicant | TOMTEC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPA |
| CFR Regulation Number | 864.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-16 |
| Decision Date | 1981-07-02 |