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 J.S. Medical Assoc..

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 Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
K113438
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 193d
Cleared Jun 15, 2006
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867
Ortho-Clinical Diagnostics, Inc.
Chemistry · 73d
Cleared Jul 16, 2004
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793
Olympus America, Inc.
Chemistry · 14d
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
K013102
Wiener Laboratories Saic
Chemistry · 57d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340
Bayer Corp.
Chemistry · 69d
Cleared May 02, 2000
DIRECT TIBC KIT
K000781
Reference Diagnostics, Inc.
Chemistry · 53d
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115
Dade Behring, Inc.
Chemistry · 53d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666
A.P. Total Care, Inc.
Chemistry · 47d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244
A.P. Total Care, Inc.
Chemistry · 43d
Cleared Feb 16, 1999
MAGNETIC TIBC KIT
K990216
Reference Diagnostics, Inc.
Chemistry · 25d
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 Jan 06, 1998
RANDOX IRON
K974604
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Aug 27, 1996
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
K961587
Diagnostic Chemicals , Ltd.
Chemistry · 125d
Cleared Aug 20, 1996
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
K963116
Diagnostic Chemicals , Ltd.
Chemistry · 8d
Cleared May 10, 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485
Beckman Instruments, Inc.
Chemistry · 98d
Cleared Feb 12, 1996
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139
Olympus America, Inc.
Chemistry · 91d
Cleared May 08, 1995
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
K946354
Data Medical Associates, Inc.
Chemistry · 129d
Cleared Nov 09, 1993
IRON/UIBC REAGENT
K932517
Sigma Diagnostics, Inc.
Chemistry · 168d
Cleared Oct 22, 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329
King Diagnostics, Inc.
Chemistry · 106d
Cleared May 26, 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493
Eastman Kodak Company
Chemistry · 62d
Cleared Aug 26, 1992
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569
Baxter Diagnostics, Inc.
Chemistry · 40d

About Product Code JMO - Regulatory Context