Zenkers Solution
FDA 510(k) K842732 · E K Ind., Inc.
510(k) numberK842732
Submission
- Device name
- Zenkers Solution
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | Volu Sol Medical Industries | 08/05/1982SE |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Zenkers Solution cleared by the FDA?
Zenkers Solution (K842732) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 21 days after the submission was received.
What is the product code of K842732?
The FDA product code is IFH – Solution, Zenker'S, a Class I (low risk) device regulated under 21 CFR 864.4010.