K840087 is an FDA 510(k) clearance for the PRESERV GOMORI TRICHROME STAIN 125/500. This device is classified as a Stains, Chemical Solution (Class I - General Controls, product code LED).
Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984, 31 days after receiving the submission on January 10, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K840087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1984 |
| Decision Date | February 10, 1984 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LED — Stains, Chemical Solution |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |