The following data is part of a premarket notification filed by Remel Co. with the FDA for Acridine Orange Stain.
| Device ID | K803304 |
| 510k Number | K803304 |
| Device Name: | ACRIDINE ORANGE STAIN |
| Classification | Acridine Orange |
| Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IDC |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-02-12 |