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
97–117 of 117
Cleared Mar 12, 1980
BUN REAGENT
K800341
Gilford Diagnostics
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM BUN
K800128
Union Carbide Corp.
Chemistry · 26d
Cleared Jan 10, 1979
BUN
K781782
Gilford Diagnostics
Chemistry · 83d
Cleared Jul 27, 1978
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K780943
Sclavo, Inc.
Hematology · 50d
Cleared May 19, 1978
UREA NITROGEN (ENZYMATIC)
K780534
Macomb Chemical Co.
Chemistry · 46d
Cleared Feb 14, 1978
BUN REAGNET SET
K780069
Medical Analysis Systems, Inc.
Chemistry · 29d
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 Apr 05, 1977
BUN, ENZYMATIC
K770315
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Dec 29, 1976
ENZYMATIC BUN (RATE) REAGENT KIT
K761261
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Nov 05, 1976
ENZYMATIC BUN REAGENT KIT
K760414
Beckman Instruments, Inc.
Chemistry · 88d