The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Donnect. Diag. Total Bilirubin Reagents.
| Device ID | K792338 |
| 510k Number | K792338 |
| Device Name: | DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | CONNECTICUT DIAGNOSTICS, LTD. 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 | 1979-11-19 |
| Decision Date | 1979-12-06 |