CDS · Class II · 21 CFR 862.1770

FDA Product Code CDS: Electrode, Ion Specific, Urea Nitrogen

Leading manufacturers include Epocal, Inc., Boehringer Mannheim Corp. and Beckman Instruments, Inc..

15
Total
15
Cleared
90d
Avg days
1976
Since

FDA 510(k) Cleared Electrode, Ion Specific, Urea Nitrogen Devices (Product Code CDS)

15 devices
1–15 of 15
Cleared Jan 17, 2018
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247
Epocal, Inc.
Chemistry · 264d
Cleared Apr 20, 1993
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550
Hichem Diagnostics
Chemistry · 168d
Cleared Aug 31, 1981
LANCER BUN RATE REAGENT KIT
K812308
Sherwood Medical Co.
Chemistry · 14d
Cleared Apr 10, 1980
BUN REAGENT KIT #88108
K800616
Hi Chem, Inc.
Chemistry · 23d
Cleared Feb 05, 1980
BUN REAGENT KIT
K800071
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Jul 21, 1977
DIAG. CONDUCTA RATE BUN REAG. SET
K771060
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jan 25, 1977
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K761061
Beckman Instruments, Inc.
Chemistry · 68d
Cleared Nov 01, 1976
BUN-REATIVE
K760430
Boehringer Mannheim Corp.
Chemistry · 80d

About Product Code CDS - Regulatory Context