Product code CDQ— Clinical Chemistry
UREA
- Classification name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Total cleared
- 117
- First cleared
- Most recent
Market context for product code CDQ
FDA has cleared devices under product code CDQ between 1976 and 2022, filed by 72 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2014
- 2011
- 2008
- 2007
- 2006
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code CDQ
Recent clearances under product code CDQ
1–100 of 117- K203771 — Urea Nitrogen2
- K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
- K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS
- K073295 — UREA/BUN, SCAL, NORTROL, ABTROL
- K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
- K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
- K041051 — RAICHEM BUN RATE REAGENT (LIQUID)
- K024182 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
- K021385 — ATAC PAK BUN REAGENT
- K012649 — RAICHEM BUN RATE REAGENT
- K012260 — WIENER LAB. UREA UV CINETICA AA
- K011596 — UREA NITROGEN (BUN) LIQUID REAGENT
- K002694 — UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
- K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
- K993925 — WAKO L-TYPE UN TEST
- K993178 — UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
- K992800 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
- K990980 — BUN, MODEL BU 104-01
- K982236 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
- K981918 — UREA
- K981123 — UREA
- K981106 — UREA NITROGEN (BUN) LIQUID REAGENT
- K980057 — CARESIDE BUN
- K974337 — IL TEST UREA NITROGEN
- K973931 — UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
- K971309 — UREA
- K972671 — BUN (LIQUID) REAGENT SET
- K971967 — BUN
- K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
- K962418 — UREA NITROGEN (BUN) LIQUI-UV
- K960115 — HICHEM BUN/UREA REAGENT KIT
- K954000 — ROCHE REAGENT FOR BUN
- K952742 — BLOOD UREA NITROGEN REAGENT SYSTEM
- K942984 — BUN REAGENT
- K944250 — UREA NITROGEN REAGENT
- K934533 — BUN-300/BUN-500 UREA NITROGEN REAGENT
- K923506 — UREA KIT
- K932161 — UREA NITROGEN TEST ITEM NUMBER 65408
- K931745 — OLYMPUS REPLY UREA NITROGEN REAGENT
- K925002 — UREA NITROGEN TEST
- K924693 — OLYMPUS BUN REAGENT
- K923035 — MILES URINE UREA NITROGEN METHOD
- K922597 — OLYMPUS UREA NITROGEN (BUN) REAGENT
- K914877 — IL TEST(TM) UREA NITROGEN
- K911248 — SYNERMED UREA NITROGEN REAGENT KIT
- K905602 — ECLIPSE ICA BUN
- K903334 — UREA NITROGEN TEST
- K902175 — COULTER UREA NITROGEN REAGENT
- K901123 — CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
- K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
- K894836 — DART UREA NITROGEN
- K895666 — BUN (KINETIC)
- K894173 — BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
- K894378 — UREA NITROGEN TEST (BUN) ITEM #65408
- K892331 — ENZYMATIC UREA NITROGEN REAGENT SET
- K891912 — AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
- K884987 — UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
- K881677 — BUN (KINETIC)
- K881366 — BIOTROL BUN ENZYMATIQUE UV H.P.
- K880078 — UREA NITROGEN (BUN)
- K873532 — PARAMAX UREA NITROGEN REAGENT
- K874477 — EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
- K873335 — WAKO(TM) AUTOKIT UREA N
- K872484 — MODIFIED ENZYMATIC BUN REAGENT
- K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE)
- K870571 — EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
- K863925 — UREA NITROGEN(BUN)
- K863260 — BLOOD UREA NITROGEN(BUN) PROCEDURE
- K863196 — BUN (RATE) REAGENT
- K861666 — BLOOD UREA NITROGEN (BUN) PROCEDURE
- K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV)
- K860716 — ENZYMATIC BUN REAGENT
- K860135 — EASY-TEST UREA (BUN) REAGENT
- K860109 — ENZYMATIC UREA NITROGEN REAGENT SET
- K853677 — TDX REA BUN
- K853102 — UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
- K852292 — DURAZYME UREA NITROGEN
- K852131 — BUN(ENDPOINT) REAGENT
- K851513 — ULTRA-VIOLET BUN REAGENT KIT
- K850923 — BUN (RATE) REAGENT
- K844755 — FOCUS UREA NITROGEN
- K844065 — ENI BLOOD UREA NITROGEN REAGENT
- K843326 — SYSTEMATE BUN HEM NO. 67221
- K843057 — UREA ASSAY KIT
- K842242 — UREA ASSAY KIT
- K840064 — UREA NITROGEN REAGENT SET
- K840785 — PARAMAX UREA NITROGEN REAGENT
- K833931 — UREA NITROGEN-UV
- K832941 — BUN LIQUID STABLE REAGENT SET
- K832749 — EASYTOUCH BUN REAGENT SET
- K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12
- K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A
- K830241 — ULTRA CHEM BUN-UV #65080-65081
- K830555 — AMRESCO UREA NITROGEN REAGENT SET
- K823300 — BUN-UN CENTRIFICHUM 500, #65080/81
- K823472 — ULTRA CHEM BAN-UV #65080 & 65081
- K823402 — ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
- K821562 — LANCER MSA BUN DIAG. KIT
- K812417 — BLOOD UREA NITROGEN(BUN-UV)
- K812341 — UREA NITROGEN (BUN)
Data sourced from openFDA. This site is unofficial and independent of the FDA.