CDS — Electrode, Ion Specific, Urea Nitrogen Class II
FDA Device Classification
Classification Details
- Product Code
- CDS
- Device Class
- Class II
- Regulation Number
- 862.1770
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K171247 | epocal | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | January 17, 2018 |
| K040973 | genchem | BUN REAGENT | December 27, 2004 |
| K033056 | diamond diagnostics | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | January 30, 2004 |
| K925550 | hichem diagnostics | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | April 20, 1993 |
| K860543 | ilex | BLOOD UREA NITROGEN (BUN) TESTCARD | April 21, 1986 |
| K855091 | sen tech medical | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | March 14, 1986 |
| K812308 | sherwood medical | LANCER BUN RATE REAGENT KIT | August 31, 1981 |
| K811193 | chem-elec | BUN RATE REAGENT | July 10, 1981 |
| K800616 | hi chem | BUN REAGENT KIT #88108 | April 10, 1980 |
| K800590 | nobel scientific industries | BUN KIT | April 4, 1980 |
| K800071 | fisher scientific co | BUN REAGENT KIT | February 5, 1980 |
| K791018 | fermco biochemics | FERMCOTEST R BUN RATE REAGENT TEST KIT | July 17, 1979 |
| K771060 | j.t. baker chemical | DIAG. CONDUCTA RATE BUN REAG. SET | July 21, 1977 |
| K761061 | beckman instruments | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | January 25, 1977 |
| K760430 | boehringer mannheim | BUN-REATIVE | November 1, 1976 |