ICF · Crystal Violet For Histology
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | ICF |
|---|---|
| Device Name | Crystal Violet For Histology |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Sigma Diagnostics, Inc. | Dec 22, 1986 | SESE |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | Oct 1, 1984 | SESE |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | Jun 3, 1982 | SESE |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | Dec 18, 1979 | SESE |
Top Applicants
- American Dade — 1 clearance
- E K Ind., Inc. — 1 clearance
- Intl. Remote Imaging Systems — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
