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 Abbott Laboratories.

117
Total
117
Cleared
65d
Avg days
1976
Since
117 devices
73–96 of 117
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 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
Cleared Dec 26, 1982
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
K823402
Emd Chemicals, Inc.
Chemistry · 41d
Cleared Jun 11, 1982
LANCER MSA BUN DIAG. KIT
K821562
Sherwood Medical Co.
Chemistry · 17d
Cleared Sep 09, 1981
BLOOD UREA NITROGEN(BUN-UV)
K812417
Reagents Applications, Inc.
Chemistry · 16d
Cleared Sep 01, 1981
UREA NITROGEN (BUN)
K812341
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Aug 31, 1981
FUN-UV SYSTEM PACK TEST
K812290
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794
Abbott Laboratories
Chemistry · 9d
Cleared Sep 26, 1980
DATA-ZYME UREA NITROGEN REAGENT SET
K802061
Data Medical Associates, Inc.
Chemistry · 32d
Cleared May 08, 1980
ENZYMATIC UREA NITROGEN REAGENT SET REVI
K800719
Macomb Chemical Co.
Chemistry · 38d
Cleared Mar 20, 1980
CENTRIFICHEM BUN
K800529
Union Carbide Corp.
Chemistry · 13d