Product code CDS
- Device name
- Electrode, Ion Specific, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1770
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | Epocal, Inc. | 2018-01-17 |
| K040973 | BUN REAGENT | Genchem, Inc. | 2004-12-27 |
| K033056 | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | Diamond Diagnostics, Inc. | 2004-01-30 |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | Hichem Diagnostics | 1993-04-20 |
| K860543 | BLOOD UREA NITROGEN (BUN) TESTCARD | Ilex Corp. | 1986-04-21 |
| K855091 | CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS | Sen Tech Medical Corp. | 1986-03-14 |
| K812308 | LANCER BUN RATE REAGENT KIT | Sherwood Medical Co. | 1981-08-31 |
| K811193 | BUN RATE REAGENT | Chem-Elec, Inc. | 1981-07-10 |
| K800616 | BUN REAGENT KIT #88108 | Hi Chem, Inc. | 1980-04-10 |
| K800590 | BUN KIT | Nobel Scientific Industries, Inc. | 1980-04-04 |
| K800071 | BUN REAGENT KIT | Fisher Scientific Co., LLC | 1980-02-05 |
| K791018 | FERMCOTEST R BUN RATE REAGENT TEST KIT | Fermco Biochemics, Inc. | 1979-07-17 |
| K771060 | DIAG. CONDUCTA RATE BUN REAG. SET | J.T. Baker Chemical Co. | 1977-07-21 |
| K761061 | BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 | Beckman Instruments, Inc. | 1977-01-25 |
| K760430 | BUN-REATIVE | Boehringer Mannheim Corp. | 1976-11-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10054749005519 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-05-01 |
| 00385480183420 | NOVA | NOVA BIOMEDICAL CORPORATION | 2017-04-24 |
| 00385480118026 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-22 |
| 00385480087964 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480364591 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480362597 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480359429 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480176125 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480165013 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480148443 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480145756 | Nova | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480142441 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480132039 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480131940 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480364614 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364577 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364553 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364539 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480115339 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131421 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480178792 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480175180 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170932 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480170925 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |