Product code ICF
- Device name
- Crystal Violet For Histology
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Sigma Diagnostics, Inc. | 1986-12-22 |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | 1984-10-01 |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | 1984-08-03 |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | 1982-06-03 |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | 1979-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00673693236478 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 00673693090001 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-05 |
| 05060472461421 | Crystal Violet | PRO-LAB, INCORPORATED | 2022-12-24 |
| 00850015517112 | KOVA | KOVA INTERNATIONAL, INC. | 2020-08-12 |
| 00855617006606 | KOVA | KOVA INTERNATIONAL, INC. | 2020-08-12 |
| 00855617006057 | KOVA | KOVA INTERNATIONAL, INC. | 2020-07-30 |
| 00850015517068 | KOVA | KOVA INTERNATIONAL, INC. | 2020-03-09 |
| 00850015517051 | KOVA | KOVA INTERNATIONAL, INC. | 2020-03-09 |
| 00850015517044 | KOVA | KOVA INTERNATIONAL, INC. | 2020-03-09 |
| 00850015517037 | KOVA | KOVA INTERNATIONAL, INC. | 2020-03-09 |
| 00850015517020 | KOVA | KOVA INTERNATIONAL, INC. | 2020-03-09 |
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