Volu-Sol Urinary Sediment Stain
FDA 510(k) K792495 · Volu Sol Medical Industries
510(k) numberK792495
Submission
- Device name
- Volu-Sol Urinary Sediment Stain
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- December 4, 1979
- Decision date
- December 18, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ICF – Crystal Violet For Histology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code ICF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K864531 | Tissue Gram StainICF · Traditional | Sigma Diagnostics, Inc. | 12/22/1986SE |
| K842537 | Von Willebrand Factor Antigen ScreenICF · Traditional | American Dade | 10/01/1984SE |
| K842730 | Gentian VioletICF · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K821503 | Iris Urine StainICF · Traditional | Intl. Remote Imaging Systems | 06/03/1982SE |
More from Intl. Remote Imaging Systems
| 510(k) | Device | Decision |
|---|---|---|
| K822129 | Volu-Sol Bovins FixativeIGN · Traditional | 08/05/1982SE |
| K822128 | Volu-Sol Single Differential StainICN · Traditional | 08/05/1982SE |
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | 08/05/1982SE |
| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Volu-Sol Urinary Sediment Stain cleared by the FDA?
Volu-Sol Urinary Sediment Stain (K792495) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 14 days after the submission was received.
What is the product code of K792495?
The FDA product code is ICF – Crystal Violet For Histology, a Class I (low risk) device regulated under 21 CFR 864.1850.