Product code CDS— Clinical Chemistry
BLOOD UREA NITROGEN (BUN) TESTCARD
- Classification name
- Electrode, Ion Specific, Urea Nitrogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code CDS
FDA has cleared devices under product code CDS between 1976 and 2018, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2004
- 1993
- 1986
- 1981
- 1980
- 1979
- 1977
- 1976
Top applicants under product code CDS
Recent clearances under product code CDS
- K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
- K040973 — BUN REAGENT
- K033056 — BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
- K925550 — HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
- K860543 — BLOOD UREA NITROGEN (BUN) TESTCARD
- K855091 — CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
- K812308 — LANCER BUN RATE REAGENT KIT
- K811193 — BUN RATE REAGENT
- K800616 — BUN REAGENT KIT #88108
- K800590 — BUN KIT
- K800071 — BUN REAGENT KIT
- K791018 — FERMCOTEST R BUN RATE REAGENT TEST KIT
- K771060 — DIAG. CONDUCTA RATE BUN REAG. SET
- K761061 — BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
- K760430 — BUN-REATIVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.