K854176 is an FDA 510(k) clearance for the POLYCHROME IV STAIN. This device is classified as a Stains, Chemical Solution (Class I - General Controls, product code LED).
Submitted by Devetec, Inc. (Bradenton, US). The FDA issued a Cleared decision on October 31, 1985, 16 days after receiving the submission on October 15, 1985.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K854176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1985 |
| Decision Date | October 31, 1985 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LED — Stains, Chemical Solution |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |