The following data is part of a premarket notification filed by Preventive Diagnostics Corp. with the FDA for Preserv Gomori Trichrome Stain 125/500.
| Device ID | K840087 |
| 510k Number | K840087 |
| Device Name: | PRESERV GOMORI TRICHROME STAIN 125/500 |
| Classification | Stains, Chemical Solution |
| Applicant | PREVENTIVE DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LED |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-02-10 |