ICF — Crystal Violet For Histology Class I
FDA product code ICF covers "Crystal Violet For Histology", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- ICF
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- 510(k) Exempt
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K864531 | Sigma Diagnostics | TISSUE GRAM STAIN | Dec 22, 1986 |
| K842537 | American Dade | VON WILLEBRAND FACTOR ANTIGEN SCREEN | Oct 1, 1984 |
| K842730 | E K Ind | GENTIAN VIOLET | Aug 3, 1984 |
| K821503 | Intl. Remote Imaging Systems | IRIS URINE STAIN | Jun 3, 1982 |
| K792495 | Volu Sol Medical Industries | VOLU-SOL URINARY SEDIMENT STAIN | Dec 18, 1979 |