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CDN — Urease, Photometric, Urea Nitrogen Class II

FDA Device Classification

Classification Details

Product Code
CDN
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
K190326ortho-clinical diagnosticsVITROS XT Chemistry Products UREA-CREA SlidesMarch 14, 2019
K132462hitachi chemical diagnosticsS TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREOctober 28, 2013
K123322alfa wassermann diagnostics technologiesACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGMay 21, 2013
K113389alfa wassermann diagnostic technologiesACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAugust 10, 2012
K103615alfa wassermann diagnostic technologiesACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANISeptember 8, 2011
K001885ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATJuly 20, 2000
K972012cholestechCHOLESTECH BUN/CREATININE TEST SYSTEMJuly 24, 1997
K961196johnson and johnson clinical diagnosticsEKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)May 15, 1996
K943042prisma systemsBUN QVETDecember 29, 1994
K922969king diagnosticsKING DIAGNOSTICS UREA NITROGEN REAGENTOctober 13, 1992
K914903em diagnostic systemsQUICKSTART UREA NITROGENDecember 31, 1991
K822154dow chemicalUREA NITROGEN (ENZYMATIC) DETERMINATIONAugust 5, 1982
K802518nobel scientific industriesBUN REAGENT ASTRA 4 & 8 ANALYZERSNovember 12, 1980
K792328boehringer mannheimSTATTEK BUNDecember 18, 1979
K781253coulter electronicsBUN (UREASE) REAGENTAugust 21, 1978
K771442instrumentation laboratoryMULTISTAT III UREA NITROGEN TESTAugust 22, 1977