The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Total Bilirubin Reagent.
| Device ID | K840486 |
| 510k Number | K840486 |
| Device Name: | TOTAL BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SOMAS MEDICAL INDUSTRIES, INC. 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 | 1984-02-06 |
| Decision Date | 1984-04-25 |