CDM · Class I · 21 CFR 862.1785

FDA Product Code CDM: Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

Leading manufacturers include Miles Laboratories, Inc., Wako Chemicals USA, Inc. and Mach Diag. C/O Wichita State University.

9
Total
9
Cleared
174d
Avg days
1979
Since

FDA 510(k) Cleared Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) Devices (Product Code CDM)

9 devices
1–9 of 9
Cleared Dec 05, 2006
URITEST 10 URINALYSIS REAGENT STRIPS
K052719
Arj Medical, Inc.
Chemistry · 432d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559
Acon Laboratories Co.
Chemistry · 67d
Cleared May 31, 1988
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
K880584
Mach Diag. C/O Wichita State University
Chemistry · 111d
Cleared Jan 21, 1988
WAKO(TM) PRETEST 5A
K873366
Wako Chemicals USA, Inc.
Chemistry · 153d
Cleared Sep 03, 1985
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611
Miles Laboratories, Inc.
Chemistry · 76d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K821799
Patton, Boggs & Blow
Chemistry · 424d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K830340
Boditestor
Hematology · 195d
Cleared Jul 28, 1983
DIA STRIPS SYSTEM
K831623
California Immuno Diagnostic, Inc.
Chemistry · 69d
Cleared Jun 28, 1979
REAGENT STRIPS FOR URINALYSIS
K790965
Miles Laboratories, Inc.
Chemistry · 37d

About Product Code CDM - Regulatory Context