The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Eosin Y Solution, Alcoholic, With Phloxine.
| Device ID | K880596 |
| 510k Number | K880596 |
| Device Name: | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE |
| Classification | Eosin Y |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Takes, Phd |
| Correspondent | Takes, Phd SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | HYB |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-11 |
| Decision Date | 1988-03-31 |