FDA 510(k) Applications for Medical Device Product Code "CDW"
(Diacetyl-Monoxime, Urea Nitrogen)

FDA 510(k) Number Applicant Device Name Decision Date
K863425 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 10/01/1986
K871320 AMERICAN RESEARCH PRODUCTS CO. FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 04/22/1987
K781305 ANALYTICAL & RESEARCH CHEMICALS, INC. UREA NITROGEN 08/31/1978
K813415 ANCO MEDICAL REAGENTS & ASSOC. UREA NITROGEN REAGENT SET 12/31/1981
K861775 BOEHRINGER MANNHEIM CORP. TWIN BUN/GLUCOSE 06/27/1986
K874532 CATACHEM, INC. BLOOD UREA NITROGEN 01/05/1988
K800673 DIAGNOSTIC SOLUTIONS, INC. SMAC REPLACEMENT REAGENTS/OF BUN-SERUM 05/28/1980
K850937 DILAB, INC. UREA 06/10/1985
K781885 FISHER SCIENTIFIC CO., LLC. SERUM, BLOOD UREA NITIOGEN 12/20/1978
K771830 GAMMA ENTERPRISES, INC. BLOOD UREA NITROGEN BUN 10/25/1977
K771087 HARLECO UNIPAK BUN 07/21/1977
K822323 HARLECO DIAGNOSTICS ULTRACHEM BUN-UV, 65080 & 65081 09/02/1982
K780262 HYCEL, INC. DIRECT UREA NITROGEN TEST 04/05/1978
K844156 LIVONIA DIAGNOSTICS, INC. UREA NITROGEN REAGENT SET 11/13/1984
K771312 MALLINCKRODT CRITICAL CARE BLOOD UREA NITROGEN (BUN) REAGENT 08/03/1977
K841068 MEDICAL SPECIALTIES, INC. UREA NITROGEN REAGENT SET 05/01/1984
K821212 OMEGA MEDICAL ELECTRONICS UREA NITROGEN REAGENT SET 07/22/1982
K802160 PANMED, INC. BUN COLOR REAGENT & BUN ACID USED 10/10/1980
K760478 SIMMLER & SON, INC. REAGENT, BUN (UREA NITROGEN) DETERM. 10/29/1976
K860419 STERLING DIAGNOSTICS, INC. UREA NITROGEN REAGENT SET 02/11/1986
K770470 WORTHINGTON BIOCHEMICAL CORP. WORTHINGTON BUN 06/02/1977


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact