VOLU-SOL URINARY SEDIMENT STAIN
FDA 510(k) clearance K792495 · decided 1979-12-18
Clearance details
- K-number
- K792495
- Device name
- VOLU-SOL URINARY SEDIMENT STAIN
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1979-12-04
- Decision date
- 1979-12-18
- Days to decision
- 14 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 |
| GENTIAN VIOLET (K842730) | E K Ind., Inc. | 1984-08-03 |
| IRIS URINE STAIN (K821503) | Intl. Remote Imaging Systems | 1982-06-03 |
Recalls involving this device
No recalls on record reference this clearance.