JMO · Class I · 21 CFR 862.1415

FDA Product Code JMO: Ferrozine (colorimetric) Iron Binding Capacity

Leading manufacturers include Abbott Laboratories, Em Diagnostic Systems, Inc. and Boehringer Mannheim Corp..

46
Total
46
Cleared
57d
Avg days
1977
Since

FDA 510(k) Cleared Ferrozine (colorimetric) Iron Binding Capacity Devices (Product Code JMO)

46 devices
1–24 of 46
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115
Dade Behring, Inc.
Chemistry · 53d
Cleared Jul 30, 1998
UIBC
K982041
Abbott Laboratories
Chemistry · 50d
Cleared Jul 22, 1998
TIBC
K981654
Abbott Laboratories
Chemistry · 72d
Cleared May 20, 1998
TIBC
K981279
Abbott Laboratories
Chemistry · 42d
Cleared May 10, 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485
Beckman Instruments, Inc.
Chemistry · 98d
Cleared May 26, 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493
Eastman Kodak Company
Chemistry · 62d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930
Abbott Laboratories
Chemistry · 22d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128
Em Diagnostic Systems, Inc.
Chemistry · 18d

About Product Code JMO - Regulatory Context