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
25–48 of 117
Cleared Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
K962418
Stanbio Laboratory
Chemistry · 185d
Cleared Mar 29, 1996
HICHEM BUN/UREA REAGENT KIT
K960115
Elan Pharma, Inc.
Chemistry · 78d
Cleared Oct 25, 1995
ROCHE REAGENT FOR BUN
K954000
Roche Diagnostic Systems, Inc.
Chemistry · 61d
Cleared Aug 11, 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Mar 01, 1995
BUN REAGENT
K942984
American Research Products Co.
Chemistry · 254d
Cleared Sep 27, 1993
UREA KIT
K923506
Randox Laboratories, Ltd.
Chemistry · 439d
Cleared Sep 08, 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161
Em Diagnostic Systems, Inc.
Chemistry · 127d
Cleared Aug 19, 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745
Olympus Corp.
Chemistry · 136d
Cleared Jan 04, 1993
UREA NITROGEN TEST
K925002
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Nov 25, 1992
OLYMPUS BUN REAGENT
K924693
Olympus Corp.
Chemistry · 70d
Cleared Sep 09, 1992
MILES URINE UREA NITROGEN METHOD
K923035
Heraeus Kulzer, Inc.
Chemistry · 82d
Cleared Jul 10, 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597
Olympus Corp.
Chemistry · 38d
Cleared Mar 11, 1992
IL TEST(TM) UREA NITROGEN
K914877
Instrumentation Laboratory CO
Chemistry · 134d
Cleared Jun 03, 1991
SYNERMED UREA NITROGEN REAGENT KIT
K911248
Synermed, Inc.
Chemistry · 74d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jun 12, 1990
COULTER UREA NITROGEN REAGENT
K902175
Coulter Corp.
Chemistry · 29d
Cleared May 10, 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123
Technicon Instruments Corp.
Chemistry · 59d
Cleared Apr 11, 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394
American Research Products Co.
Chemistry · 72d
Cleared Oct 30, 1989
DART UREA NITROGEN
K894836
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Oct 27, 1989
BUN (KINETIC)
K895666
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Sep 05, 1989
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
K894173
Catachem, Inc.
Chemistry · 82d
Cleared Aug 31, 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378
Em Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Jun 20, 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331
American Monitor Corp.
Chemistry · 76d
Cleared Jun 19, 1989
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
K891912
American Research Products Co.
Chemistry · 84d