CDS — Electrode, Ion Specific, Urea Nitrogen Class II
FDA product code CDS covers "Electrode, Ion Specific, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. Submissions are reviewed by the Clinical Chemistry panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |