CDL · Class II · 21 CFR 862.1770

FDA Product Code CDL: Berthelot Indophenol, Urea Nitrogen

Leading manufacturers include Volu Sol Medical Industries, U. S. Diagnostics, Inc. and Tech-Co, Inc..

16
Total
16
Cleared
36d
Avg days
1976
Since

FDA 510(k) Cleared Berthelot Indophenol, Urea Nitrogen Devices (Product Code CDL)

16 devices
1–16 of 16
Cleared Feb 16, 1990
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
K896845
Reagents Applications, Inc.
Chemistry · 72d
Cleared Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
K893128
Stanbio Laboratory
Chemistry · 91d
Cleared May 12, 1987
COLORIMETRIC BUN REAGENT KIT
K871651
Biochemical Trade, Inc.
Chemistry · 14d
Cleared Jan 13, 1987
UREA NITROGEN(BUN), COLORIMETRIC METHOD
K864742
Tech-Co, Inc.
Chemistry · 40d
Cleared Nov 24, 1986
UREA NITROGEN TEST
K863889
U. S. Diagnostics, Inc.
Chemistry · 49d
Cleared Sep 09, 1986
UREAFAST
K863076
J. D. Assoc.
Chemistry · 28d
Cleared Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 16, 1983
COLORIMETRIC BUN
K831414
Bio-Analytics Laboratories, Inc.
Chemistry · 45d
Cleared Feb 10, 1981
EUROCHIMA UREA NITROGEN
K810261
Volu Sol Medical Industries
Chemistry · 11d
Cleared Sep 09, 1980
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727
Data Medical Associates, Inc.
Chemistry · 47d
Cleared Jun 09, 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
K800902
Sclavo, Inc.
Chemistry · 52d
Cleared Dec 07, 1979
ELVI BLOOD UREA NITROGEN
K792417
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 09, 1976
S-UREA-N, IN VITRO DIAG FOR BUN
K761152
Advanced Biomedical Methods, Inc.
Chemistry · 10d

About Product Code CDL - Regulatory Context