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CDW — Diacetyl-Monoxime, Urea Nitrogen Class II

FDA Device Classification

FDA product code CDW covers "Diacetyl-Monoxime, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CDW
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
K874532catachemBLOOD UREA NITROGENJanuary 5, 1988
K871320american research productsFLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814April 22, 1987
K863425american research productsAMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346October 1, 1986
K861775boehringer mannheimTWIN BUN/GLUCOSEJune 27, 1986
K860419sterling diagnosticsUREA NITROGEN REAGENT SETFebruary 11, 1986
K850937dilabUREAJune 10, 1985
K844156livonia diagnosticsUREA NITROGEN REAGENT SETNovember 13, 1984
K841068medical specialtiesUREA NITROGEN REAGENT SETMay 1, 1984
K822323harleco diagnosticsULTRACHEM BUN-UV, 65080 & 65081September 2, 1982
K821212omega medical electronicsUREA NITROGEN REAGENT SETJuly 22, 1982
K813415anco medical reagents and assocUREA NITROGEN REAGENT SETDecember 31, 1981
K802160panmedBUN COLOR REAGENT & BUN ACID USEDOctober 10, 1980
K800673diagnostic solutionsSMAC REPLACEMENT REAGENTS/OF BUN-SERUMMay 28, 1980
K781885fisher scientific coSERUM, BLOOD UREA NITIOGENDecember 20, 1978
K781305analytical and research chemicalsUREA NITROGENAugust 31, 1978
K780262hycelDIRECT UREA NITROGEN TESTApril 5, 1978
K771830gamma enterprisesBLOOD UREA NITROGEN BUNOctober 25, 1977
K771312mallinckrodt critical careBLOOD UREA NITROGEN (BUN) REAGENTAugust 3, 1977
K771087harlecoUNIPAK BUNJuly 21, 1977
K770470worthington biochemicalWORTHINGTON BUNJune 2, 1977

FDA data resources