FDA Product Code CDL: Berthelot Indophenol, Urea Nitrogen
Leading manufacturers include Volu Sol Medical Industries, Advanced Biomedical Methods, Inc. and Analytical & Research Chemicals, Inc..
16
Total
16
Cleared
36d
Avg days
1976
Since
FDA 510(k) Cleared Berthelot Indophenol, Urea Nitrogen Devices (Product Code CDL)
16 devices
Cleared
Feb 16, 1990
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
Reagents Applications, Inc.
Chemistry
72d
Cleared
Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
Stanbio Laboratory
Chemistry
91d
Cleared
May 12, 1987
COLORIMETRIC BUN REAGENT KIT
Biochemical Trade, Inc.
Chemistry
14d
Cleared
Jan 13, 1987
UREA NITROGEN(BUN), COLORIMETRIC METHOD
Tech-Co, Inc.
Chemistry
40d
Cleared
Nov 24, 1986
UREA NITROGEN TEST
U. S. Diagnostics, Inc.
Chemistry
49d
Cleared
Sep 09, 1986
UREAFAST
J. D. Assoc.
Chemistry
28d
Cleared
Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
Sterling Diagnostics, Inc.
Chemistry
21d
Cleared
Jun 16, 1983
COLORIMETRIC BUN
Bio-Analytics Laboratories, Inc.
Chemistry
45d
Cleared
Aug 16, 1982
UREA NITROGEN REAGENT SET (MOD. BERTHEL
Sterling Biochemical, Inc.
Chemistry
19d
Cleared
Feb 10, 1981
EUROCHIMA UREA NITROGEN
Volu Sol Medical Industries
Chemistry
11d
Cleared
Sep 09, 1980
DATA-ZYME UREA NITROGEN, COLORIMETRIC
Data Medical Associates, Inc.
Chemistry
47d
Cleared
Jun 09, 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
Sclavo, Inc.
Chemistry
52d
Cleared
Dec 07, 1979
ELVI BLOOD UREA NITROGEN
Volu Sol Medical Industries
Chemistry
11d
Cleared
Dec 20, 1978
UREA NITROGEN TEST
Wako Intl., Inc.
Chemistry
37d
Cleared
Aug 31, 1978
UREA NITROGEN TEST KIT
Analytical & Research Chemicals, Inc.
Chemistry
34d
Cleared
Dec 09, 1976
S-UREA-N, IN VITRO DIAG FOR BUN
Advanced Biomedical Methods, Inc.
Chemistry
10d