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CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen Class II

FDA Device Classification

Classification Details

Product Code
CDQ
Device Class
Class II
Regulation Number
862.1770
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203771abbott ireland diagnostics divisionUrea Nitrogen2May 31, 2022
K140690shenzhen mindray bio-medical electronics coBS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERSeptember 2, 2014
K110675medicaEASYRA UREA NITROGEN AND CREATININE REAGENTSApril 21, 2011
K073295thermofisher scientificUREA/BUN, SCAL, NORTROL, ABTROLMay 29, 2008
K070146horiba abxABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPOctober 12, 2007
K060120teco diagnosticsTECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMMarch 27, 2006
K041051hemagen diagnosticsRAICHEM BUN RATE REAGENT (LIQUID)June 30, 2004
K024182precision systemsPRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTSMarch 3, 2003
K021385elan diagnosticsATAC PAK BUN REAGENTJuly 12, 2002
K012649hemagen diagnosticsRAICHEM BUN RATE REAGENTOctober 15, 2001
K012260wiener laboratories saicWIENER LAB. UREA UV CINETICA AASeptember 19, 2001
K011596jas diagnosticUREA NITROGEN (BUN) LIQUID REAGENTJuly 17, 2001
K002694diagnostic chemicalsUREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30September 15, 2000
K000958elan holdingsATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITSMay 24, 2000
K993925wako chemicals usaWAKO L-TYPE UN TESTApril 3, 2000
K993178diagnostic chemicalsUREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50October 18, 1999
K992800sigma diagnosticsSIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000PSeptember 28, 1999
K990980a.p. total careBUN, MODEL BU 104-01May 25, 1999
K982236sigma diagnosticsSIGMA DIAGNOSTICS INFINITY BUN REAGENT KITAugust 5, 1998
K981918abbott laboratoriesUREAJuly 28, 1998