FDA Product Code
FDA Product Code CDQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1770
510(k) Clearances — 117 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | 2022-05-31 | Traditional | PDF ↗ |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-09-02 | Traditional | PDF ↗ |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | 2011-04-21 | Traditional | PDF ↗ |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-29 | Traditional | PDF ↗ |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Horiba Abx | 2007-10-12 | Traditional | PDF ↗ |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | 2006-03-27 | Traditional | PDF ↗ |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | Precision Systems, Inc. | 2003-03-03 | Traditional | PDF ↗ |
| K021385 | ATAC PAK BUN REAGENT | Elan Diagnostics | 2002-07-12 | Traditional | PDF ↗ |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K012260 | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | 2001-09-19 | Traditional | PDF ↗ |
| K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | 2001-07-17 | Traditional | PDF ↗ |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | 2000-09-15 | Special | PDF ↗ |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | 2000-05-24 | Traditional | PDF ↗ |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | 2000-04-03 | Traditional | PDF ↗ |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | 1999-10-18 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K990980 | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | Sigma Diagnostics, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K981918 | UREA | Abbott Laboratories | 1998-07-28 | Traditional | PDF ↗ |
| K981123 | UREA | Trace Scientific , Ltd. | 1998-04-24 | Traditional | PDF ↗ |
| K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | Teco Diagnostics | 1998-04-16 | Traditional | PDF ↗ |
| K980057 | CARESIDE BUN | Exigent Diagnostics, Inc. | 1998-02-05 | Traditional | PDF ↗ |
| K974337 | IL TEST UREA NITROGEN | Instrumentation Laboratory CO | 1997-12-17 | Traditional | PDF ↗ |
| K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 | Diagnostic Chemicals , Ltd. | 1997-11-24 | Traditional | PDF ↗ |
| K971309 | UREA | Derma Media Lab., Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K972671 | BUN (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-07-20 | Traditional | PDF ↗ |
| K971967 | BUN | Carolina Liquid Chemistries Corp. | 1997-06-17 | Traditional | PDF ↗ |
| K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | Trace America, Inc. | 1997-05-27 | Traditional | PDF ↗ |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | Stanbio Laboratory | 1996-12-26 | Traditional | PDF ↗ |
| K960115 | HICHEM BUN/UREA REAGENT KIT | Elan Pharma, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K954000 | ROCHE REAGENT FOR BUN | Roche Diagnostic Systems, Inc. | 1995-10-25 | Traditional | PDF ↗ |
| K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K942984 | BUN REAGENT | American Research Products Co. | 1995-03-01 | Traditional | PDF ↗ |
| K944250 | UREA NITROGEN REAGENT | Olympus Corp of America | 1995-02-08 | Traditional | PDF ↗ |
| K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT | Horizon Diagnostics, Inc. | 1993-11-26 | Traditional | PDF ↗ |
| K923506 | UREA KIT | Randox Laboratories, Ltd. | 1993-09-27 | Traditional | PDF ↗ |
| K932161 | UREA NITROGEN TEST ITEM NUMBER 65408 | Em Diagnostic Systems, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K931745 | OLYMPUS REPLY UREA NITROGEN REAGENT | Olympus Corp. | 1993-08-19 | Traditional | PDF ↗ |
| K925002 | UREA NITROGEN TEST | Em Diagnostic Systems, Inc. | 1993-01-04 | Traditional | PDF ↗ |
| K924693 | OLYMPUS BUN REAGENT | Olympus Corp. | 1992-11-25 | Traditional | PDF ↗ |
| K923035 | MILES URINE UREA NITROGEN METHOD | Heraeus Kulzer, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K922597 | OLYMPUS UREA NITROGEN (BUN) REAGENT | Olympus Corp. | 1992-07-10 | Traditional | PDF ↗ |
| K914877 | IL TEST(TM) UREA NITROGEN | Instrumentation Laboratory CO | 1992-03-11 | Traditional | PDF ↗ |
| K911248 | SYNERMED UREA NITROGEN REAGENT KIT | Synermed, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K905602 | ECLIPSE ICA BUN | Biotope, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K903334 | UREA NITROGEN TEST | Em Diagnostic Systems, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K902175 | COULTER UREA NITROGEN REAGENT | Coulter Corp. | 1990-06-12 | Traditional | PDF ↗ |
| K901123 | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN | Technicon Instruments Corp. | 1990-05-10 | Traditional | PDF ↗ |
| K900394 | AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 | American Research Products Co. | 1990-04-11 | Traditional | PDF ↗ |
| K894836 | DART UREA NITROGEN | Coulter Electronics, Inc. | 1989-10-30 | Traditional | PDF ↗ |
| K895666 | BUN (KINETIC) | Boehringer Mannheim Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K894173 | BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT | Catachem, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K894378 | UREA NITROGEN TEST (BUN) ITEM #65408 | Em Diagnostic Systems, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | American Monitor Corp. | 1989-06-20 | Traditional | PDF ↗ |
| K891912 | AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 | American Research Products Co. | 1989-06-19 | Traditional | PDF ↗ |
| K884987 | UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 | Em Diagnostic Systems, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K881677 | BUN (KINETIC) | Boehringer Mannheim Corp. | 1988-06-07 | Traditional | PDF ↗ |
| K881366 | BIOTROL BUN ENZYMATIQUE UV H.P. | Biotrol, USA, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K880078 | UREA NITROGEN (BUN) | Tech-Neal Scientific, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874477 | EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 | Em Diagnostic Systems, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K873532 | PARAMAX UREA NITROGEN REAGENT | Baxter Healthcare Corp | 1987-11-23 | Traditional | PDF ↗ |
| K873335 | WAKO(TM) AUTOKIT UREA N | Wako Chemicals USA, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K872484 | MODIFIED ENZYMATIC BUN REAGENT | Trace Scientific , Ltd. | 1987-08-19 | Traditional | PDF ↗ |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | Biochemical Trade, Inc. | 1987-06-22 | Traditional | PDF ↗ |
| K870571 | EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 | Em Diagnostic Systems, Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K863925 | UREA NITROGEN(BUN) | Tech-Co, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863260 | BLOOD UREA NITROGEN(BUN) PROCEDURE | Data Medical Associates, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K863196 | BUN (RATE) REAGENT | Sigma Diagnostics, Inc. | 1986-08-26 | Traditional | PDF ↗ |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | Sterling Diagnostics, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861666 | BLOOD UREA NITROGEN (BUN) PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K860716 | ENZYMATIC BUN REAGENT | Trace Scientific , Ltd. | 1986-04-24 | Traditional | PDF ↗ |
| K860135 | EASY-TEST UREA (BUN) REAGENT | Em Diagnostic Systems, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K860109 | ENZYMATIC UREA NITROGEN REAGENT SET | Technostics Intl. | 1986-02-06 | Traditional | PDF ↗ |
| K853677 | TDX REA BUN | Abbott Laboratories | 1985-09-16 | Traditional | PDF ↗ |
| K853102 | UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN | Diagnostic Chemicals, Ltd. (Usa) | 1985-08-02 | Traditional | PDF ↗ |
| K852292 | DURAZYME UREA NITROGEN | American Monitor Corp. | 1985-07-08 | Traditional | PDF ↗ |
| K852131 | BUN(ENDPOINT) REAGENT | Sigma Diagnostics, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K850923 | BUN (RATE) REAGENT | Sigma Diagnostics, Inc. | 1985-03-20 | Traditional | PDF ↗ |
| K844755 | FOCUS UREA NITROGEN | Abbott Laboratories | 1985-01-08 | Traditional | PDF ↗ |
| K844065 | ENI BLOOD UREA NITROGEN REAGENT | Electro-Nucleonics Laboratories, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843326 | SYSTEMATE BUN HEM NO. 67221 | Em Diagnostic Systems, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K843057 | UREA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-27 | Traditional | PDF ↗ |
| K842242 | UREA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K840064 | UREA NITROGEN REAGENT SET | Sterling Biochemical, Inc. | 1984-06-14 | Traditional | PDF ↗ |
| K840785 | PARAMAX UREA NITROGEN REAGENT | American Dade | 1984-04-05 | Traditional | PDF ↗ |
| K833931 | UREA NITROGEN-UV | Seragen Diagnostics, Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K832941 | BUN LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K832749 | EASYTOUCH BUN REAGENT SET | Worthington Diagnostic Systems | 1983-10-14 | Traditional | PDF ↗ |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | American Scientific Products | 1983-07-07 | Traditional | PDF ↗ |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | American Scientific Products | 1983-07-07 | Traditional | PDF ↗ |
| K830241 | ULTRA CHEM BUN-UV #65080-65081 | Emd Chemicals, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K830555 | AMRESCO UREA NITROGEN REAGENT SET | Amresco, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823300 | BUN-UN CENTRIFICHUM 500, #65080/81 | Emd Chemicals, Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K823472 | ULTRA CHEM BAN-UV #65080 & 65081 | Emd Chemicals, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823402 | ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& | Emd Chemicals, Inc. | 1982-12-26 | Traditional | PDF ↗ |
| K821562 | LANCER MSA BUN DIAG. KIT | Sherwood Medical Co. | 1982-06-11 | Traditional | PDF ↗ |
| K812417 | BLOOD UREA NITROGEN(BUN-UV) | Reagents Applications, Inc. | 1981-09-09 | Traditional | PDF ↗ |
| K812341 | UREA NITROGEN (BUN) | Pointe Scientific, Inc., | 1981-09-01 | Traditional | PDF ↗ |
Product code CDQ · Class II · Clinical Chemistry. Data: openFDA.