Crystal Violet For Histology
FDA product code ICF · Class I (low risk) · 21 CFR 864.1850 · Hematology
5510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864531 | Tissue Gram StainICF · Traditional | Sigma Diagnostics, Inc. | 12/22/1986SE |
| K842537 | Von Willebrand Factor Antigen ScreenICF · Traditional | American Dade | 10/01/1984SE |
| K842730 | Gentian VioletICF · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K821503 | Iris Urine StainICF · Traditional | Intl. Remote Imaging Systems | 06/03/1982SE |
| K792495 | Volu-Sol Urinary Sediment StainICF · Traditional | Volu Sol Medical Industries | 12/18/1979SE |