Panels › Clinical Chemistry › Product code CDQ · Class 2
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Regulation 862.1770
0510(k)s in 12 months (117 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in CDQ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2022 | K203771 | Urea Nitrogen2 Abbott Ireland Diagnostics Division, IE | CDQ |
| Sep 2, 2014 | K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | CDQ |
| Apr 21, 2011 | K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS Medica Corp. | CDQ |
| May 29, 2008 | K073295 | UREA/BUN, SCAL, NORTROL, ABTROL Thermofisher Scientific OY, FI | CDQ |
| Oct 12, 2007 | K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP Horiba Abx, FR | CDQ |
| Mar 27, 2006 | K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM Teco Diagnostics | CDQ |
| Jun 30, 2004 | K041051 | RAICHEM BUN RATE REAGENT (LIQUID) Hemagen Diagnostics, Inc. | CDQ |
| Mar 3, 2003 | K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS Precision Systems, Inc. | CDQ |
| Jul 12, 2002 | K021385 | ATAC PAK BUN REAGENT Elan Diagnostics | CDQ |
| Oct 15, 2001 | K012649 | RAICHEM BUN RATE REAGENT Hemagen Diagnostics, Inc. | CDQ |
| Sep 19, 2001 | K012260 | WIENER LAB. UREA UV CINETICA AA Wiener Laboratories Saic, AR | CDQ |
| Jul 17, 2001 | K011596 | UREA NITROGEN (BUN) LIQUID REAGENT Jas Diagnostic, Inc. | CDQ |
| Sep 15, 2000 | K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 Diagnostic Chemicals , Ltd., CA | CDQ |
| May 24, 2000 | K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS Elan Holdings, Inc. | CDQ |
| Apr 3, 2000 | K993925 | WAKO L-TYPE UN TEST Wako Chemicals USA, Inc. | CDQ |
| Oct 18, 1999 | K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 Diagnostic Chemicals , Ltd., CA | CDQ |
| Sep 28, 1999 | K992800 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P Sigma Diagnostics, Inc. | CDQ |
| May 25, 1999 | K990980 | BUN, MODEL BU 104-01 A.P. Total Care, Inc. | CDQ |
| Aug 5, 1998 | K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT Sigma Diagnostics, Inc. | CDQ |
| Jul 28, 1998 | K981918 | UREA Abbott Laboratories | CDQ |
| Apr 24, 1998 | K981123 | UREA Trace Scientific , Ltd., AU | CDQ |
| Apr 16, 1998 | K981106 | UREA NITROGEN (BUN) LIQUID REAGENT Teco Diagnostics | CDQ |
| Feb 5, 1998 | K980057 | CARESIDE BUN Exigent Diagnostics, Inc. | CDQ |
| Dec 17, 1997 | K974337 | IL TEST UREA NITROGEN Instrumentation Laboratory CO | CDQ |
| Nov 24, 1997 | K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 Diagnostic Chemicals , Ltd., CA | CDQ |
| Aug 1, 1997 | K971309 | UREA Derma Media Lab., Inc. | CDQ |
| Jul 20, 1997 | K972671 | BUN (LIQUID) REAGENT SET Pointe Scientific, Inc., | CDQ |
| Jun 17, 1997 | K971967 | BUN Carolina Liquid Chemistries Corp. | CDQ |
| May 27, 1997 | K971477 | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) Trace America, Inc. | CDQ |
| Dec 26, 1996 | K962418 | UREA NITROGEN (BUN) LIQUI-UV Stanbio Laboratory | CDQ |
| Mar 29, 1996 | K960115 | HICHEM BUN/UREA REAGENT KIT Elan Pharma, Inc. | CDQ |
| Oct 25, 1995 | K954000 | ROCHE REAGENT FOR BUN Roche Diagnostic Systems, Inc. | CDQ |
| Aug 11, 1995 | K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CDQ |
| Mar 1, 1995 | K942984 | BUN REAGENT American Research Products Co. | CDQ |
| Feb 8, 1995 | K944250 | UREA NITROGEN REAGENT Olympus Corp of America | CDQ |
| Nov 26, 1993 | K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT Horizon Diagnostics, Inc. | CDQ |
| Sep 27, 1993 | K923506 | UREA KIT Randox Laboratories, Ltd., IR | CDQ |
| Sep 8, 1993 | K932161 | UREA NITROGEN TEST ITEM NUMBER 65408 Em Diagnostic Systems, Inc. | CDQ |
| Aug 19, 1993 | K931745 | OLYMPUS REPLY UREA NITROGEN REAGENT Olympus Corp. | CDQ |
| Jan 4, 1993 | K925002 | UREA NITROGEN TEST Em Diagnostic Systems, Inc. | CDQ |
| Nov 25, 1992 | K924693 | OLYMPUS BUN REAGENT Olympus Corp. | CDQ |
| Sep 9, 1992 | K923035 | MILES URINE UREA NITROGEN METHOD Heraeus Kulzer, Inc. | CDQ |
| Jul 10, 1992 | K922597 | OLYMPUS UREA NITROGEN (BUN) REAGENT Olympus Corp. | CDQ |
| Mar 11, 1992 | K914877 | IL TEST(TM) UREA NITROGEN Instrumentation Laboratory CO | CDQ |
| Jun 3, 1991 | K911248 | SYNERMED UREA NITROGEN REAGENT KIT Synermed, Inc., CA | CDQ |
| Jan 16, 1991 | K905602 | ECLIPSE ICA BUN Biotope, Inc. | CDQ |
| Sep 7, 1990 | K903334 | UREA NITROGEN TEST Em Diagnostic Systems, Inc. | CDQ |
| Jun 12, 1990 | K902175 | COULTER UREA NITROGEN REAGENT Coulter Corp. | CDQ |
| May 10, 1990 | K901123 | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN Technicon Instruments Corp. | CDQ |
| Apr 11, 1990 | K900394 | AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 American Research Products Co. | CDQ |
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