CDN · Class II · 21 CFR 862.1770

FDA Product Code CDN: Urease, Photometric, Urea Nitrogen

Leading manufacturers include Ortho-Clinical Diagnostics, Inc., Alfa Wassermann Diagnostic Technologies, Inc. and Alfa Wassermann Diagnostics Technologies, LLC.

16
Total
16
Cleared
92d
Avg days
1977
Since

FDA 510(k) Cleared Urease, Photometric, Urea Nitrogen Devices (Product Code CDN)

16 devices
1–16 of 16
Cleared Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
K190326
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462
Hitachi Chemical Diagnostics, Inc.
Chemistry · 82d
Cleared May 21, 2013
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
K123322
Alfa Wassermann Diagnostics Technologies, LLC
Chemistry · 207d
Cleared Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 268d
Cleared Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
K103615
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 273d
Cleared Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012
Cholestech Corp.
Chemistry · 55d
Cleared May 15, 1996
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 29, 1994
BUN QVET
K943042
Prisma Systems
Chemistry · 185d
Cleared Oct 13, 1992
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969
King Diagnostics, Inc.
Chemistry · 116d
Cleared Dec 31, 1991
QUICKSTART UREA NITROGEN
K914903
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Aug 05, 1982
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154
The Dow Chemical Co.
Chemistry · 13d
Cleared Nov 12, 1980
BUN REAGENT ASTRA 4 & 8 ANALYZERS
K802518
Nobel Scientific Industries, Inc.
Toxicology · 28d
Cleared Dec 18, 1979
STATTEK BUN
K792328
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Aug 21, 1978
BUN (UREASE) REAGENT
K781253
Coulter Electronics, Inc.
Chemistry · 31d
Cleared Aug 22, 1977
MULTISTAT III UREA NITROGEN TEST
K771442
Instrumentation Laboratory CO
Chemistry · 21d

About Product Code CDN - Regulatory Context