JGZClass II
O-phthalaldehyde, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances11All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
11 clearances for this product code
- Roche Diagnostic Systems, Inc.Oct 12, 1990
K904049 · ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
- Roche Diagnostic Systems, Inc.Feb 27, 1990
K896236 · COBAS READY BUN REAGENT
- Heraeus Kulzer, Inc.Jan 23, 1989
K883327 · CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
- Bd Becton Dickinson Vacutainer Systems PreanalyticNov 24, 1986
K863901 · IQ UREA NITROGEN
- Pharmacia, Inc.Nov 1, 1984
K842772 · PHARMACIA B2-MICRO RIA
- Sclavo, Inc.Mar 19, 1984
K840213 · BLOOD UREA NITROGEN REAGENT SYS
- King Diagnostics, Inc.Mar 11, 1982
K820418 · K.D. COLORIMETRIC BLOOD UREA N2 TEST
- Bio-Analytics Laboratories, Inc.Feb 26, 1981
K810087 · UREA NITROGEN, KINETIC