The following data is part of a premarket notification filed by Fermco Biochemics, Inc. with the FDA for Fermcotest R Bun Rate Reagent Test Kit.
| Device ID | K791018 |
| 510k Number | K791018 |
| Device Name: | FERMCOTEST R BUN RATE REAGENT TEST KIT |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | FERMCO BIOCHEMICS, 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 | 1979-06-01 |
| Decision Date | 1979-07-17 |