Volu-Sol Urinary Dichrome Stain
FDA 510(k) K801143 · Volu Sol Medical Industries
510(k) numberK801143
Submission
- Device name
- Volu-Sol Urinary Dichrome Stain
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- May 18, 1980
- Decision date
- May 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IDA – Alcian Blue
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code IDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832496 | Bio Sure StainIDA · Traditional | Helena Laboratories | 09/12/1983SE |
More from Helena Laboratories
| 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 Dichrome Stain cleared by the FDA?
Volu-Sol Urinary Dichrome Stain (K801143) received a 510(k) decision of Substantially Equivalent on May 30, 1980, 12 days after the submission was received.
What is the product code of K801143?
The FDA product code is IDA – Alcian Blue, a Class I (low risk) device regulated under 21 CFR 864.1850.