FDA Product Code CDN: Urease, Photometric, Urea Nitrogen
Leading manufacturers include Em Diagnostic Systems, Inc., Ortho-Clinical Diagnostics, Inc. and Instrumentation Laboratory CO.
16
Total
16
Cleared
92d
Avg days
1977
Since
FDA 510(k) Cleared Urease, Photometric, Urea Nitrogen Devices (Product Code CDN)
16 devices
Cleared
Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
29d
Cleared
Dec 31, 1991
QUICKSTART UREA NITROGEN
Em Diagnostic Systems, Inc.
Chemistry
60d
Cleared
Dec 18, 1979
STATTEK BUN
Boehringer Mannheim Corp.
Chemistry
29d
Cleared
Aug 22, 1977
MULTISTAT III UREA NITROGEN TEST
Instrumentation Laboratory CO
Chemistry
21d