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 Trace Scientific , Ltd..

46
Total
46
Cleared
57d
Avg days
1977
Since
46 devices
25–46 of 46
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 Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128
Em Diagnostic Systems, Inc.
Chemistry · 18d
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