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
117 devices
49–72 of 117
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
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 May 16, 1988
BIOTROL BUN ENZYMATIQUE UV H.P.
K881366
Biotrol, USA, Inc.
Chemistry · 46d
Cleared Feb 11, 1988
UREA NITROGEN (BUN)
K880078
Tech-Neal Scientific, Inc.
Chemistry · 31d
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 Oct 02, 1987
WAKO(TM) AUTOKIT UREA N
K873335
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Aug 19, 1987
MODIFIED ENZYMATIC BUN REAGENT
K872484
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Jun 22, 1987
ULTRA-VIOLET BUN REAGENT KIT (RATE)
K871547
Biochemical Trade, Inc.
Chemistry · 63d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Nov 24, 1986
UREA NITROGEN(BUN)
K863925
Tech-Co, Inc.
Chemistry · 47d
Cleared Sep 09, 1986
BLOOD UREA NITROGEN(BUN) PROCEDURE
K863260
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Aug 26, 1986
BUN (RATE) REAGENT
K863196
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Jul 01, 1986
BLOOD UREA NITROGEN (BUN) PROCEDURE
K861666
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Apr 24, 1986
ENZYMATIC BUN REAGENT
K860716
Trace Scientific , Ltd.
Chemistry · 57d