Product code CDN
- Device name
- Urease, Photometric, 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 |
|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 |
| K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2013-05-21 |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | 2000-07-20 |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | 1997-07-24 |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-15 |
| K943042 | BUN QVET | Prisma Systems | 1994-12-29 |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | 1992-10-13 |
| K914903 | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | 1991-12-31 |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | 1982-08-05 |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | 1980-11-12 |
| K792328 | STATTEK BUN | Boehringer Mannheim Corp. | 1979-12-18 |
| K781253 | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | 1978-08-21 |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | 1977-08-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10758750031788 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 00857969006266 | ACE | ALFA WASSERMANN, INC. | 2016-09-24 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000331 | Piccolo Kidney Check | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000061 | Piccolo General Chemistry 6 | ABAXIS, INC. | 2016-09-23 |
| EABA40000341 | Piccolo MetLyte Plus CRP | ABAXIS, INC. | 2016-09-23 |
| EABA40000311 | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000271 | Piccolo Renal Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000241 | Piccolo Basic Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000231 | Piccolo MetLyte 8 Panel | ABAXIS, INC. | 2016-09-23 |
| 10758750004362 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 10758750004973 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 10758750004980 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |