The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Neutral Red.
| Device ID | K871477 |
| 510k Number | K871477 |
| Device Name: | NEUTRAL RED |
| Classification | Neutral Red |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | William Starkweather |
| Correspondent | William Starkweather SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KFE |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-04-29 |