The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Bilirubin Reagent Total/direct.
| Device ID | K841892 |
| 510k Number | K841892 |
| Device Name: | RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | REAGENTS APPLICATIONS, 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 | 1984-05-07 |
| Decision Date | 1984-06-07 |