GENTIAN VIOLET
FDA 510(k) clearance K842730 · decided 1984-08-03
Clearance details
- K-number
- K842730
- Device name
- GENTIAN VIOLET
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-08-03
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- ICF
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TISSUE GRAM STAIN (K864531) | Sigma Diagnostics, Inc. | 1986-12-22 |
| VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537) | American Dade | 1984-10-01 |
| IRIS URINE STAIN (K821503) | Intl. Remote Imaging Systems | 1982-06-03 |
| VOLU-SOL URINARY SEDIMENT STAIN (K792495) | Volu Sol Medical Industries | 1979-12-18 |
Recalls involving this device
No recalls on record reference this clearance.