The following data is part of a premarket notification filed by American Dade with the FDA for Direct Bilirubin Reagent.
| Device ID | K840777 |
| 510k Number | K840777 |
| Device Name: | DIRECT BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-08 |
| Decision Date | 1984-04-05 |