Atlas FDA

CDQ

117 FDA 510(k) clearances · Product code

46 daysmedian time to decision
134 days90th percentile
117clearances measured

FDA profile

Official device name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1770
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 6 · 2011: 37 · 2012: 44 · 2016: 231
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Urea Nitrogen2 (K203771)Abbott Ireland Diagnostics Division2022-05-31
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER (K140690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-09-02
EASYRA UREA NITROGEN AND CREATININE REAGENTS (K110675)Medica Corp.2011-04-21
UREA/BUN, SCAL, NORTROL, ABTROL (K073295)Thermofisher Scientific OY2008-05-29
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (K070146)Horiba Abx2007-10-12
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (K060120)Teco Diagnostics2006-03-27
RAICHEM BUN RATE REAGENT (LIQUID) (K041051)Hemagen Diagnostics, Inc.2004-06-30
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (K024182)Precision Systems, Inc.2003-03-03
ATAC PAK BUN REAGENT (K021385)Elan Diagnostics2002-07-12
RAICHEM BUN RATE REAGENT (K012649)Hemagen Diagnostics, Inc.2001-10-15
WIENER LAB. UREA UV CINETICA AA (K012260)Wiener Laboratories Saic2001-09-19
UREA NITROGEN (BUN) LIQUID REAGENT (K011596)Jas Diagnostic, Inc.2001-07-17
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 (K002694)Diagnostic Chemicals , Ltd.2000-09-15
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (K000958)Elan Holdings, Inc.2000-05-24
WAKO L-TYPE UN TEST (K993925)Wako Chemicals USA, Inc.2000-04-03
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 (K993178)Diagnostic Chemicals , Ltd.1999-10-18
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P (K992800)Sigma Diagnostics, Inc.1999-09-28
BUN, MODEL BU 104-01 (K990980)A.P. Total Care, Inc.1999-05-25
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT (K982236)Sigma Diagnostics, Inc.1998-08-05
UREA (K981918)Abbott Laboratories1998-07-28
UREA (K981123)Trace Scientific , Ltd.1998-04-24
UREA NITROGEN (BUN) LIQUID REAGENT (K981106)Teco Diagnostics1998-04-16
CARESIDE BUN (K980057)Exigent Diagnostics, Inc.1998-02-05
IL TEST UREA NITROGEN (K974337)Instrumentation Laboratory CO1997-12-17
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 (K973931)Diagnostic Chemicals , Ltd.1997-11-24
UREA (K971309)Derma Media Lab., Inc.1997-08-01
BUN (LIQUID) REAGENT SET (K972671)Pointe Scientific, Inc.,1997-07-20
BUN (K971967)Carolina Liquid Chemistries Corp.1997-06-17
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K971477)Trace America, Inc.1997-05-27
UREA NITROGEN (BUN) LIQUI-UV (K962418)Stanbio Laboratory1996-12-26
HICHEM BUN/UREA REAGENT KIT (K960115)Elan Pharma, Inc.1996-03-29
ROCHE REAGENT FOR BUN (K954000)Roche Diagnostic Systems, Inc.1995-10-25
BLOOD UREA NITROGEN REAGENT SYSTEM (K952742)Medical Diagnostic Technologies, Inc.1995-08-11
BUN REAGENT (K942984)American Research Products Co.1995-03-01
UREA NITROGEN REAGENT (K944250)Olympus Corp of America1995-02-08
BUN-300/BUN-500 UREA NITROGEN REAGENT (K934533)Horizon Diagnostics, Inc.1993-11-26
UREA KIT (K923506)Randox Laboratories, Ltd.1993-09-27
UREA NITROGEN TEST ITEM NUMBER 65408 (K932161)Em Diagnostic Systems, Inc.1993-09-08
OLYMPUS REPLY UREA NITROGEN REAGENT (K931745)Olympus Corp.1993-08-19
UREA NITROGEN TEST (K925002)Em Diagnostic Systems, Inc.1993-01-04
OLYMPUS BUN REAGENT (K924693)Olympus Corp.1992-11-25
MILES URINE UREA NITROGEN METHOD (K923035)Heraeus Kulzer, Inc.1992-09-09
OLYMPUS UREA NITROGEN (BUN) REAGENT (K922597)Olympus Corp.1992-07-10
IL TEST(TM) UREA NITROGEN (K914877)Instrumentation Laboratory CO1992-03-11
SYNERMED UREA NITROGEN REAGENT KIT (K911248)Synermed, Inc.1991-06-03
ECLIPSE ICA BUN (K905602)Biotope, Inc.1991-01-16
UREA NITROGEN TEST (K903334)Em Diagnostic Systems, Inc.1990-09-07
COULTER UREA NITROGEN REAGENT (K902175)Coulter Corp.1990-06-12
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN (K901123)Technicon Instruments Corp.1990-05-10
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (K900394)American Research Products Co.1990-04-11
DART UREA NITROGEN (K894836)Coulter Electronics, Inc.1989-10-30
BUN (KINETIC) (K895666)Boehringer Mannheim Corp.1989-10-27
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT (K894173)Catachem, Inc.1989-09-05
UREA NITROGEN TEST (BUN) ITEM #65408 (K894378)Em Diagnostic Systems, Inc.1989-08-31
ENZYMATIC UREA NITROGEN REAGENT SET (K892331)American Monitor Corp.1989-06-20
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 (K891912)American Research Products Co.1989-06-19
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 (K884987)Em Diagnostic Systems, Inc.1989-01-13
BUN (KINETIC) (K881677)Boehringer Mannheim Corp.1988-06-07
BIOTROL BUN ENZYMATIQUE UV H.P. (K881366)Biotrol, USA, Inc.1988-05-16
UREA NITROGEN (BUN) (K880078)Tech-Neal Scientific, Inc.1988-02-11
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 (K874477)Em Diagnostic Systems, Inc.1987-11-23
PARAMAX UREA NITROGEN REAGENT (K873532)Baxter Healthcare Corp1987-11-23
WAKO(TM) AUTOKIT UREA N (K873335)Wako Chemicals USA, Inc.1987-10-02
MODIFIED ENZYMATIC BUN REAGENT (K872484)Trace Scientific , Ltd.1987-08-19
ULTRA-VIOLET BUN REAGENT KIT (RATE) (K871547)Biochemical Trade, Inc.1987-06-22
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 (K870571)Em Diagnostic Systems, Inc.1987-03-04
UREA NITROGEN(BUN) (K863925)Tech-Co, Inc.1986-11-24
BLOOD UREA NITROGEN(BUN) PROCEDURE (K863260)Data Medical Associates, Inc.1986-09-09
BUN (RATE) REAGENT (K863196)Sigma Diagnostics, Inc.1986-08-26
BLOOD UREA NITROGEN (BUN) PROCEDURE (K861666)Data Medical Associates, Inc.1986-07-01
UREA NITROGEN (GLDH) REAGENT SET (UV) (K862210)Sterling Diagnostics, Inc.1986-07-01
ENZYMATIC BUN REAGENT (K860716)Trace Scientific , Ltd.1986-04-24
EASY-TEST UREA (BUN) REAGENT (K860135)Em Diagnostic Systems, Inc.1986-02-21
ENZYMATIC UREA NITROGEN REAGENT SET (K860109)Technostics Intl.1986-02-06
TDX REA BUN (K853677)Abbott Laboratories1985-09-16
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN (K853102)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
DURAZYME UREA NITROGEN (K852292)American Monitor Corp.1985-07-08
BUN(ENDPOINT) REAGENT (K852131)Sigma Diagnostics, Inc.1985-06-10
ULTRA-VIOLET BUN REAGENT KIT (K851513)Bio-Analytics Laboratories, Inc.1985-05-20
BUN (RATE) REAGENT (K850923)Sigma Diagnostics, Inc.1985-03-20
FOCUS UREA NITROGEN (K844755)Abbott Laboratories1985-01-08
ENI BLOOD UREA NITROGEN REAGENT (K844065)Electro-Nucleonics Laboratories, Inc.1984-11-27
SYSTEMATE BUN HEM NO. 67221 (K843326)Em Diagnostic Systems, Inc.1984-09-14
UREA ASSAY KIT (K843057)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
UREA ASSAY KIT (K842242)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
UREA NITROGEN REAGENT SET (K840064)Sterling Biochemical, Inc.1984-06-14
PARAMAX UREA NITROGEN REAGENT (K840785)American Dade1984-04-05
UREA NITROGEN-UV (K833931)Seragen Diagnostics, Inc.1984-01-13
BUN LIQUID STABLE REAGENT SET (K832941)Medical Analysis Systems, Inc.1983-10-28
EASYTOUCH BUN REAGENT SET (K832749)Worthington Diagnostic Systems1983-10-14
UREA NITROGEN-BUN-REAGENTS B6360-12 (K831625)American Scientific Products1983-07-07
UREA NITROGEN-BUN-REAGENTS B6370-11A (K831626)American Scientific Products1983-07-07
ULTRA CHEM BUN-UV #65080-65081 (K830241)Emd Chemicals, Inc.1983-04-05
AMRESCO UREA NITROGEN REAGENT SET (K830555)Amresco, Inc.1983-03-24
BUN-UN CENTRIFICHUM 500, #65080/81 (K823300)Emd Chemicals, Inc.1983-01-09
ULTRA CHEM BAN-UV #65080 & 65081 (K823472)Emd Chemicals, Inc.1982-12-28
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& (K823402)Emd Chemicals, Inc.1982-12-26
LANCER MSA BUN DIAG. KIT (K821562)Sherwood Medical Co.1982-06-11
BLOOD UREA NITROGEN(BUN-UV) (K812417)Reagents Applications, Inc.1981-09-09
UREA NITROGEN (BUN) (K812341)Pointe Scientific, Inc.,1981-09-01
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