CDW · Class II · 21 CFR 862.1770

FDA Product Code CDW: Diacetyl-monoxime, Urea Nitrogen

Leading manufacturers include American Research Products Co., Fisher Scientific Co., LLC and Diagnostic Solutions, Inc..

21
Total
21
Cleared
44d
Avg days
1976
Since

FDA 510(k) Cleared Diacetyl-monoxime, Urea Nitrogen Devices (Product Code CDW)

21 devices
1–21 of 21
Cleared Jan 05, 1988
BLOOD UREA NITROGEN
K874532
Catachem, Inc.
Chemistry · 63d
Cleared Apr 22, 1987
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
K871320
American Research Products Co.
Chemistry · 19d
Cleared Oct 01, 1986
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
K863425
American Research Products Co.
Chemistry · 27d
Cleared Jun 27, 1986
TWIN BUN/GLUCOSE
K861775
Boehringer Mannheim Corp.
Chemistry · 50d
Cleared Feb 11, 1986
UREA NITROGEN REAGENT SET
K860419
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared May 01, 1984
UREA NITROGEN REAGENT SET
K841068
Medical Specialties, Inc.
Chemistry · 50d
Cleared Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
K822323
Harleco Diagnostics
Chemistry · 30d
Cleared Jul 22, 1982
UREA NITROGEN REAGENT SET
K821212
Omega Medical Electronics
Chemistry · 86d
Cleared Dec 31, 1981
UREA NITROGEN REAGENT SET
K813415
Anco Medical Reagents & Assoc.
Chemistry · 24d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Dec 20, 1978
SERUM, BLOOD UREA NITIOGEN
K781885
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Apr 05, 1978
DIRECT UREA NITROGEN TEST
K780262
Hycel, Inc.
Chemistry · 47d
Cleared Oct 25, 1977
BLOOD UREA NITROGEN BUN
K771830
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared Aug 03, 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Jul 21, 1977
UNIPAK BUN
K771087
Harleco
Chemistry · 35d

About Product Code CDW - Regulatory Context