CDQ · Class II · 21 CFR 862.1770

FDA Product Code CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

Leading manufacturers include Em Diagnostic Systems, Inc., Sigma Diagnostics, Inc. and Emd Chemicals, Inc..

117
Total
117
Cleared
65d
Avg days
1976
Since
117 devices
73–96 of 117
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 06, 1986
ENZYMATIC UREA NITROGEN REAGENT SET
K860109
Technostics Intl.
Chemistry · 24d
Cleared Sep 16, 1985
TDX REA BUN
K853677
Abbott Laboratories
Chemistry · 12d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 10d
Cleared Jul 08, 1985
DURAZYME UREA NITROGEN
K852292
American Monitor Corp.
Chemistry · 40d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared May 20, 1985
ULTRA-VIOLET BUN REAGENT KIT
K851513
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared Mar 20, 1985
BUN (RATE) REAGENT
K850923
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755
Abbott Laboratories
Chemistry · 33d
Cleared Nov 27, 1984
ENI BLOOD UREA NITROGEN REAGENT
K844065
Electro-Nucleonics Laboratories, Inc.
Chemistry · 40d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Aug 27, 1984
UREA ASSAY KIT
K843057
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 18, 1984
UREA ASSAY KIT
K842242
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jun 14, 1984
UREA NITROGEN REAGENT SET
K840064
Sterling Biochemical, Inc.
Chemistry · 157d
Cleared Apr 05, 1984
PARAMAX UREA NITROGEN REAGENT
K840785
American Dade
Chemistry · 50d
Cleared Jan 13, 1984
UREA NITROGEN-UV
K833931
Seragen Diagnostics, Inc.
Chemistry · 60d
Cleared Oct 28, 1983
BUN LIQUID STABLE REAGENT SET
K832941
Medical Analysis Systems, Inc.
Chemistry · 59d
Cleared Oct 14, 1983
EASYTOUCH BUN REAGENT SET
K832749
Worthington Diagnostic Systems
Chemistry · 60d
Cleared Jul 07, 1983
UREA NITROGEN-BUN-REAGENTS B6360-12
K831625
American Scientific Products
Chemistry · 48d
Cleared Jul 07, 1983
UREA NITROGEN-BUN-REAGENTS B6370-11A
K831626
American Scientific Products
Chemistry · 48d
Cleared Apr 05, 1983
ULTRA CHEM BUN-UV #65080-65081
K830241
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Mar 24, 1983
AMRESCO UREA NITROGEN REAGENT SET
K830555
Amresco, Inc.
Chemistry · 29d
Cleared Jan 09, 1983
BUN-UN CENTRIFICHUM 500, #65080/81
K823300
Emd Chemicals, Inc.
Chemistry · 65d
Cleared Dec 28, 1982
ULTRA CHEM BAN-UV #65080 & 65081
K823472
Emd Chemicals, Inc.
Chemistry · 36d