Volu-Sol Zenkers Fixative
FDA 510(k) K822127 · Volu Sol Medical Industries
510(k) numberK822127
Submission
- Device name
- Volu-Sol Zenkers Fixative
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- July 19, 1982
- Decision date
- August 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842732 | Zenkers SolutionIFH · Traditional | E K Ind., Inc. | 08/03/1984SE |
More from E K Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822129 | Volu-Sol Bovins FixativeIGN · Traditional | 08/05/1982SE |
| K822128 | Volu-Sol Single Differential StainICN · 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 |
| K821540 | Hematoxylin IIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Volu-Sol Zenkers Fixative cleared by the FDA?
Volu-Sol Zenkers Fixative (K822127) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 17 days after the submission was received.
What is the product code of K822127?
The FDA product code is IFH – Solution, Zenker'S, a Class I (low risk) device regulated under 21 CFR 864.4010.