The following data is part of a premarket notification filed by Simmler & Son, Inc. with the FDA for Reagent, Total Bilirubin Determination.
| Device ID | K760479 |
| 510k Number | K760479 |
| Device Name: | REAGENT, TOTAL BILIRUBIN DETERMINATION |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SIMMLER & SON, 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 | 1976-08-17 |
| Decision Date | 1976-10-29 |