The following data is part of a premarket notification filed by Omega Medical Electronics with the FDA for Total Bilirubin Reagent Set.
| Device ID | K821197 |
| 510k Number | K821197 |
| Device Name: | TOTAL BILIRUBIN REAGENT SET |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | OMEGA MEDICAL ELECTRONICS 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 | 1982-04-27 |
| Decision Date | 1982-07-13 |