CDQ · Class II · 21 CFR 862.1770

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

Leading manufacturers include Em Diagnostic Systems, Inc., Boehringer Mannheim Corp. and Abbott Laboratories.

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 Jul 28, 1998
UREA
K981918
Abbott Laboratories
Chemistry · 57d
Cleared Dec 17, 1997
IL TEST UREA NITROGEN
K974337
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Oct 25, 1995
ROCHE REAGENT FOR BUN
K954000
Roche Diagnostic Systems, Inc.
Chemistry · 61d
Cleared Sep 08, 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161
Em Diagnostic Systems, Inc.
Chemistry · 127d
Cleared Jan 04, 1993
UREA NITROGEN TEST
K925002
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Mar 11, 1992
IL TEST(TM) UREA NITROGEN
K914877
Instrumentation Laboratory CO
Chemistry · 134d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Oct 27, 1989
BUN (KINETIC)
K895666
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Aug 31, 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378
Em Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jun 07, 1988
BUN (KINETIC)
K881677
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Nov 23, 1987
PARAMAX UREA NITROGEN REAGENT
K873532
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Sep 16, 1985
TDX REA BUN
K853677
Abbott Laboratories
Chemistry · 12d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755
Abbott Laboratories
Chemistry · 33d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326
Em Diagnostic Systems, Inc.
Chemistry · 18d
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 Nov 11, 1977
FASTCHEM BUN
K771923
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Jun 24, 1977
UN, UV DELTA TEST ASSAY
K770654
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 79d
Cleared Dec 29, 1976
ENZYMATIC BUN (RATE) REAGENT KIT
K761261
Beckman Instruments, Inc.
Chemistry · 13d

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.