JGZ · Class II · 21 CFR 862.1770

FDA Product Code JGZ: O-phthalaldehyde, Urea Nitrogen

Leading manufacturers include Roche Diagnostic Systems, Inc., American Monitor Corp. and Miles Laboratories, Inc..

11
Total
11
Cleared
70d
Avg days
1977
Since

FDA 510(k) Cleared O-phthalaldehyde, Urea Nitrogen Devices (Product Code JGZ)

11 devices
1–11 of 11
Cleared Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
K904049
Roche Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 27, 1990
COBAS READY BUN REAGENT
K896236
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327
Heraeus Kulzer, Inc.
Chemistry · 168d
Cleared Nov 24, 1986
IQ UREA NITROGEN
K863901
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 48d
Cleared Nov 01, 1984
PHARMACIA B2-MICRO RIA
K842772
Pharmacia, Inc.
Immunology · 108d
Cleared Mar 19, 1984
BLOOD UREA NITROGEN REAGENT SYS
K840213
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 11, 1982
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418
King Diagnostics, Inc.
Chemistry · 23d
Cleared Jul 08, 1980
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269
Miles Laboratories, Inc.
Chemistry · 41d
Cleared Jun 27, 1977
REAGENT SYSTEM
K770504
American Monitor Corp.
Chemistry · 103d

About Product Code JGZ - Regulatory Context