CDN · Class II · 21 CFR 862.1770

FDA Product Code CDN: Urease, Photometric, Urea Nitrogen

Leading manufacturers include Ortho-Clinical Diagnostics, Inc., Instrumentation Laboratory CO and Coulter Electronics, Inc..

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 Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
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 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