The following data is part of a premarket notification filed by Chem-elec, Inc. with the FDA for Bun Rate Reagent.
| Device ID | K811193 |
| 510k Number | K811193 |
| Device Name: | BUN RATE REAGENT |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | CHEM-ELEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-30 |
| Decision Date | 1981-07-10 |