The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Sigma Sudan Black Reagent 380-1.
| Device ID | K843684 |
| 510k Number | K843684 |
| Device Name: | SIGMA SUDAN BLACK REAGENT 380-1 |
| Classification | Sudan Black B |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | HZZ |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-18 |
| Decision Date | 1984-10-31 |