Sudan IV Herxheimer
FDA 510(k) K842916 · E K Ind., Inc.
510(k) numberK842916
Submission
- Device name
- Sudan IV Herxheimer
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 25, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KKK – Sudan Iv
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
More from E K Ind., Inc.
| 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 Sudan IV Herxheimer cleared by the FDA?
Sudan IV Herxheimer (K842916) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 48 days after the submission was received.
What is the product code of K842916?
The FDA product code is KKK – Sudan Iv, a Class I (low risk) device regulated under 21 CFR 864.1850.