The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Total & Direct Bilirubin Procedures.
| Device ID | K832942 |
| 510k Number | K832942 |
| Device Name: | TOTAL & DIRECT BILIRUBIN PROCEDURES |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SANDARE CHEMICAL CO., 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 | 1983-08-30 |
| Decision Date | 1983-11-07 |