JMO · Class I · 21 CFR 862.1415

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

Leading manufacturers include Abbott Laboratories, J.S. Medical Assoc. and Em Diagnostic Systems, Inc..

46
Total
46
Cleared
57d
Avg days
1977
Since
46 devices
25–46 of 46
Cleared Jul 21, 1992
SYNERMED UIBC REAGENT KIT
K922784
Synermed, Inc.
Chemistry · 42d
Cleared Sep 25, 1991
J&S IRON REAGENTS
K912716
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 25, 1991
J&S UIBC REAGENTS
K912717
J.S. Medical Assoc.
Chemistry · 99d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 12, 1991
BIOTROL UIBC REAGENT
K912795
Biotrol, USA, Inc.
Chemistry · 48d
Cleared Sep 27, 1990
IRON 5 X CONC REAGENT
K904116
Trace Scientific , Ltd.
Chemistry · 21d
Cleared May 31, 1990
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960
American Research Products Co.
Chemistry · 30d
Cleared Jul 20, 1989
J&S IRON SATURATING REAGENTS
K893662
J.S. Medical Assoc.
Chemistry · 66d
Cleared Oct 25, 1988
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104
Technicon Instruments Corp.
Chemistry · 92d
Cleared Jul 08, 1988
UNSATURATED IRON BINDING CAPACITY
K881761
Data Medical Associates, Inc.
Chemistry · 74d
Cleared Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Oct 28, 1987
IRON REAGENT
K874055
Trace Scientific , Ltd.
Chemistry · 23d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Sep 16, 1986
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426
American Research Products Co.
Chemistry · 12d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930
Abbott Laboratories
Chemistry · 22d
Cleared May 07, 1985
SANDARE IRON-BINDING CAPACITY PROCEDURE
K851395
Sandare Chemical Co., Inc.
Chemistry · 28d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Oct 14, 1983
TOTAL IRON-BINDING CAPACITY ACCESORY
K832759
Seragen Diagnostics, Inc.
Chemistry · 56d
Cleared May 25, 1983
SERUM UIBC-PTF-600 METHOD
K831202
American Monitor Corp.
Chemistry · 42d
Cleared Feb 13, 1978
IRON BINDING CAPACITY CHEMISTRY
K780094
Harleco
Chemistry · 26d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927
Harleco
Chemistry · 31d
Cleared Jun 01, 1977
TEST, FERROZINE IRON & IRON BINDING
K770748
Hycel, Inc.
Chemistry · 40d