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
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Urease And Glutamic Dehydrogenase, Urea Nitrogen Devices (Product Code CDQ)

117 devices
1–24 of 117
Cleared May 31, 2022
Urea Nitrogen2
K203771
Abbott Ireland Diagnostics Division
Chemistry · 524d
Cleared Sep 02, 2014
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
K140690
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Chemistry · 167d
Cleared Apr 21, 2011
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675
Medica Corp.
Chemistry · 42d
Cleared Mar 27, 2006
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120
Teco Diagnostics
Chemistry · 69d
Cleared Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
K041051
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Sep 15, 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694
Diagnostic Chemicals , Ltd.
Chemistry · 17d
Cleared Apr 03, 2000
WAKO L-TYPE UN TEST
K993925
Wako Chemicals USA, Inc.
Chemistry · 137d
Cleared Oct 18, 1999
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178
Diagnostic Chemicals , Ltd.
Chemistry · 25d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236
Sigma Diagnostics, Inc.
Chemistry · 41d
Cleared Jul 28, 1998
UREA
K981918
Abbott Laboratories
Chemistry · 57d
Cleared Apr 24, 1998
UREA
K981123
Trace Scientific , Ltd.
Chemistry · 28d
Cleared Apr 16, 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106
Teco Diagnostics
Chemistry · 21d
Cleared Dec 17, 1997
IL TEST UREA NITROGEN
K974337
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Nov 24, 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931
Diagnostic Chemicals , Ltd.
Chemistry · 40d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671
Pointe Scientific, Inc.,
Chemistry · 4d
Cleared Dec 26, 1996
UREA NITROGEN (BUN) LIQUI-UV
K962418
Stanbio Laboratory
Chemistry · 185d
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

About Product Code CDQ - Regulatory Context

510(k) Submission Activity

117 total 510(k) submissions under product code CDQ since 1976, with 117 receiving FDA clearance (average review time: 65 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.