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 Boehringer Mannheim Corp..

117
Total
117
Cleared
65d
Avg days
1976
Since
117 devices
25–48 of 117
Cleared Nov 24, 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931
Diagnostic Chemicals , Ltd.
Chemistry · 40d
Cleared Aug 01, 1997
UREA
K971309
Derma Media Lab., Inc.
Chemistry · 115d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671
Pointe Scientific, Inc.,
Chemistry · 4d
Cleared Jun 17, 1997
BUN
K971967
Carolina Liquid Chemistries Corp.
Chemistry · 20d
Cleared May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477
Trace America, Inc.
Chemistry · 34d
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 Feb 08, 1995
UREA NITROGEN REAGENT
K944250
Olympus Corp of America
Chemistry · 160d
Cleared Nov 26, 1993
BUN-300/BUN-500 UREA NITROGEN REAGENT
K934533
Horizon Diagnostics, Inc.
Chemistry · 70d
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 Jan 16, 1991
ECLIPSE ICA BUN
K905602
Biotope, Inc.
Chemistry · 34d
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