The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Sudan Iv Herxheimer.
| Device ID | K842916 |
| 510k Number | K842916 |
| Device Name: | SUDAN IV HERXHEIMER |
| Classification | Sudan Iv |
| Applicant | E K IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KKK |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-25 |
| Decision Date | 1984-09-11 |