The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Bun Reagent Kit #88108.
| Device ID | K800616 |
| 510k Number | K800616 |
| Device Name: | BUN REAGENT KIT #88108 |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | HI CHEM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-18 |
| Decision Date | 1980-04-10 |