Product code CDQ
- Device name
- Urease And Glutamic Dehydrogenase, 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 |
|---|---|---|---|
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | 2022-05-31 |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-09-02 |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | 2011-04-21 |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-29 |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Horiba Abx | 2007-10-12 |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | 2006-03-27 |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 |
| K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | Precision Systems, Inc. | 2003-03-03 |
| K021385 | ATAC PAK BUN REAGENT | Elan Diagnostics | 2002-07-12 |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 |
| K012260 | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | 2001-09-19 |
| K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | 2001-07-17 |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | 2000-09-15 |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | 2000-05-24 |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | 2000-04-03 |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | 1999-10-18 |
| K992800 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P | Sigma Diagnostics, Inc. | 1999-09-28 |
| K990980 | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | Sigma Diagnostics, Inc. | 1998-08-05 |
| K981918 | UREA | Abbott Laboratories | 1998-07-28 |
| K981123 | UREA | Trace Scientific , Ltd. | 1998-04-24 |
| K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | Teco Diagnostics | 1998-04-16 |
| K980057 | CARESIDE BUN | Exigent Diagnostics, Inc. | 1998-02-05 |
| K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 | Diagnostic Chemicals , Ltd. | 1997-11-24 |
| K971309 | UREA | Derma Media Lab., Inc. | 1997-08-01 |
| K972671 | BUN (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-07-20 |
| K971967 | BUN | Carolina Liquid Chemistries Corp. | 1997-06-17 |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1997-05-27 |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | Stanbio Laboratory | 1996-12-26 |
| K960115 | HICHEM BUN/UREA REAGENT KIT | Elan Pharma, Inc. | 1996-03-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654119 | Atellica CH UN_c | Siemens Healthcare Diagnostics Inc. | 2026-03-18 |
| 06944904084459 | Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-01-23 |
| 10673486013726 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013894 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013962 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013580 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 00850053916069 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-09 |
| 10673486001228 | Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set | TECO DIAGNOSTICS | 2023-07-21 |
| 10673486001259 | Teco Diagnostics Urea Nitrogen (BUN) Reagent Set | TECO DIAGNOSTICS | 2023-07-21 |
| 10673486001242 | Teco Diagnostics Urea Nitrogen (BUN) Reagent Set | TECO DIAGNOSTICS | 2023-07-21 |
| 10673486001235 | Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480 | TECO DIAGNOSTICS | 2023-07-21 |
| 00811727016058 | Pointe BUN Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 03610230007211 | Yumizen C1200 Urea | HORIBA ABX SAS | 2020-08-28 |
| 00811727015747 | Pointe BUN on BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 07613336121603 | Urea/Bun | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740161781 | ARCHITECT | Abbott GmbH | 2020-01-25 |
| 00380740161774 | ARCHITECT | Abbott GmbH | 2020-01-25 |
| 05055273216172 | UREA | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 00386100001988 | BUN Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 15099590050405 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590020163 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590010386 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590010317 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 04015630911790 | Kinetic UV assay for ureaurea nitrogen | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630911806 | Kinetic UV assay for ureaurea nitrogen | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630920464 | UreaBUN | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921966 | UREABUN | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630991372 | Kinetic UV assay for ureaurea nitrogen | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925131 | UreaBUN | Roche Diagnostics GmbH | 2016-09-20 |
| 03610230005040 | ABX PENTRA UREA CP | HORIBA ABX SAS | 2016-08-23 |