FDA 510(k) Applications for Medical Device Product Code "CDQ"
(Urease And Glutamic Dehydrogenase, Urea Nitrogen)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990980 | A.P. TOTAL CARE, INC. | BUN, MODEL BU 104-01 | 05/25/1999 |
| K203771 | Abbott Ireland Diagnostics Division | Urea Nitrogen2 | 05/31/2022 |
| K981918 | ABBOTT LABORATORIES | UREA | 07/28/1998 |
| K971967 | CAROLINA LIQUID CHEMISTRIES CORP. | BUN | 06/17/1997 |
| K971309 | DERMA MEDIA LAB., INC. | UREA | 08/01/1997 |
| K993178 | DIAGNOSTIC CHEMICALS LTD. | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | 10/18/1999 |
| K002694 | DIAGNOSTIC CHEMICALS LTD. | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | 09/15/2000 |
| K973931 | DIAGNOSTIC CHEMICALS LTD. | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 | 11/24/1997 |
| K021385 | ELAN DIAGNOSTICS | ATAC PAK BUN REAGENT | 07/12/2002 |
| K000958 | ELAN HOLDINGS, INC. | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | 05/24/2000 |
| K960115 | ELAN PHARMA, INC. | HICHEM BUN/UREA REAGENT KIT | 03/29/1996 |
| K980057 | EXIGENT DIAGNOSTICS, INC. | CARESIDE BUN | 02/05/1998 |
| K012649 | HEMAGEN DIAGNOSTICS, INC. | RAICHEM BUN RATE REAGENT | 10/15/2001 |
| K041051 | HEMAGEN DIAGNOSTICS, INC. | RAICHEM BUN RATE REAGENT (LIQUID) | 06/30/2004 |
| K070146 | HORIBA ABX | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | 10/12/2007 |
| K974337 | INSTRUMENTATION LABORATORY CO. | IL TEST UREA NITROGEN | 12/17/1997 |
| K011596 | JAS DIAGNOSTIC, INC. | UREA NITROGEN (BUN) LIQUID REAGENT | 07/17/2001 |
| K110675 | MEDICA CORP. | EASYRA UREA NITROGEN AND CREATININE REAGENTS | 04/21/2011 |
| K972671 | POINTE SCIENTIFIC, INC. | BUN (LIQUID) REAGENT SET | 07/20/1997 |
| K024182 | PRECISION SYSTEMS, INC. | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | 03/03/2003 |
| K140690 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | 09/02/2014 |
| K982236 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | 08/05/1998 |
| K992800 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P | 09/28/1999 |
| K962418 | STANBIO LABORATORY | UREA NITROGEN (BUN) LIQUI-UV | 12/26/1996 |
| K060120 | TECO DIAGNOSTICS | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | 03/27/2006 |
| K981106 | TECO DIAGNOSTICS | UREA NITROGEN (BUN) LIQUID REAGENT | 04/16/1998 |
| K073295 | THERMO FISHER SCIENTIFIC OY | UREA/BUN, SCAL, NORTROL, ABTROL | 05/29/2008 |
| K971477 | TRACE AMERICA, INC. | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) | 05/27/1997 |
| K981123 | TRACE SCIENTIFIC LTD. | UREA | 04/24/1998 |
| K993925 | WAKO CHEMICALS, USA, INC. | WAKO L-TYPE UN TEST | 04/03/2000 |
| K012260 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. UREA UV CINETICA AA | 09/19/2001 |
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