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Panels › Clinical Chemistry › Product code CDW · Class 2

Diacetyl-Monoxime, Urea Nitrogen

Regulation 862.1770

0510(k)s in 12 months (21 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in CDW

Decided510(k)Device and applicantCode
Jan 5, 1988K874532BLOOD UREA NITROGEN
Catachem, Inc.
CDW
Apr 22, 1987K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
American Research Products Co.
CDW
Oct 1, 1986K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
American Research Products Co.
CDW
Jun 27, 1986K861775TWIN BUN/GLUCOSE
Boehringer Mannheim Corp.
CDW
Feb 11, 1986K860419UREA NITROGEN REAGENT SET
Sterling Diagnostics, Inc.
CDW
Jun 10, 1985K850937UREA
Dilab, Inc.
CDW
Nov 13, 1984K844156UREA NITROGEN REAGENT SET
Livonia Diagnostics, Inc.
CDW
May 1, 1984K841068UREA NITROGEN REAGENT SET
Medical Specialties, Inc.
CDW
Sep 2, 1982K822323ULTRACHEM BUN-UV, 65080 & 65081
Harleco Diagnostics
CDW
Jul 22, 1982K821212UREA NITROGEN REAGENT SET
Omega Medical Electronics
CDW
Dec 31, 1981K813415UREA NITROGEN REAGENT SET
Anco Medical Reagents & Assoc.
CDW
Oct 10, 1980K802160BUN COLOR REAGENT & BUN ACID USED
Panmed, Inc.
CDW
May 28, 1980K800673SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
Diagnostic Solutions, Inc.
CDW
Dec 20, 1978K781885SERUM, BLOOD UREA NITIOGEN
Fisher Scientific Co., LLC
CDW
Aug 31, 1978K781305UREA NITROGEN
Analytical & Research Chemicals, Inc.
CDW
Apr 5, 1978K780262DIRECT UREA NITROGEN TEST
Hycel, Inc.
CDW
Oct 25, 1977K771830BLOOD UREA NITROGEN BUN
Gamma Enterprises, Inc.
CDW
Aug 3, 1977K771312BLOOD UREA NITROGEN (BUN) REAGENT
Mallinckrodt Critical Care
CDW
Jul 21, 1977K771087UNIPAK BUN
Harleco
CDW
Jun 2, 1977K770470WORTHINGTON BUN
Worthington Biochemical Corp.
CDW
Oct 29, 1976K760478REAGENT, BUN (UREA NITROGEN) DETERM.
Simmler & Son, Inc.
CDW

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