JGZ · Class II · 21 CFR 862.1770

FDA Product Code JGZ: O-phthalaldehyde, Urea Nitrogen

Leading manufacturers include Roche Diagnostic Systems, Inc., Miles Laboratories, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 Jul 08, 1980
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269
Miles Laboratories, Inc.
Chemistry · 41d

About Product Code JGZ - Regulatory Context