Ferrozine (Colorimetric) Iron Binding Capacity

FDA product code JMO · 46 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1415
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-06-01 – 2012-06-01

JMO 2012-06-01

ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K113438

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JMO 2006-06-15

VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

Applicant Ortho-Clinical Diagnostics, Inc.

K number K061464

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JMO 2005-12-23

VITROS CHEMISTRY PRODUCTS DTIBC REAGENT

Applicant Ortho-Clinical Diagnostics, Inc.

K number K052867

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JMO 2004-07-16

OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524

Applicant Olympus America, Inc.

K number K041793

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JMO 2001-11-13

WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002

Applicant Wiener Laboratories Saic

K number K013102

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JMO 2001-10-01

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

Applicant Bayer Corp.

K number K012340

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JMO 2000-05-02

DIRECT TIBC KIT

Applicant Reference Diagnostics, Inc.

K number K000781

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JMO 2000-01-28

TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K994115

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JMO 1999-06-30

TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02

Applicant A.P. Total Care, Inc.

K number K991666

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JMO 1999-05-25

TOTAL IRON, MODELS FE 109-01, FE 109-02

Applicant A.P. Total Care, Inc.

K number K991244

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JMO 1999-02-16

MAGNETIC TIBC KIT

Applicant Reference Diagnostics, Inc.

K number K990216

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JMO 1998-07-30

UIBC

Applicant Abbott Laboratories

K number K982041

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JMO 1998-07-22

TIBC

Applicant Abbott Laboratories

K number K981654

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JMO 1998-05-20

TIBC

Applicant Abbott Laboratories

K number K981279

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JMO 1998-01-06

RANDOX IRON

Applicant Randox Laboratories, Ltd.

K number K974604

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JMO 1996-08-27

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25

Applicant Diagnostic Chemicals , Ltd.

K number K961587

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JMO 1996-08-20

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

Applicant Diagnostic Chemicals , Ltd.

K number K963116

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JMO 1996-05-10

SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS

Applicant Beckman Instruments, Inc.

K number K960485

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JMO 1996-02-12

OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT

Applicant Olympus America, Inc.

K number K955139

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JMO 1995-05-08

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE

Applicant Data Medical Associates, Inc.

K number K946354

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JMO 1993-11-09

IRON/UIBC REAGENT

Applicant Sigma Diagnostics, Inc.

K number K932517

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JMO 1993-10-22

KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT

Applicant King Diagnostics, Inc.

K number K933329

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JMO 1993-05-26

KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT

Applicant Eastman Kodak Company

K number K931493

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JMO 1992-08-26

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT

Applicant Baxter Diagnostics, Inc.

K number K923569

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JMO 1992-07-21

SYNERMED UIBC REAGENT KIT

Applicant Synermed, Inc.

K number K922784

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JMO 1991-09-25

J&S UIBC REAGENTS

Applicant J.S. Medical Assoc.

K number K912717

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JMO 1991-09-25

J&S IRON REAGENTS

Applicant J.S. Medical Assoc.

K number K912716

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JMO 1991-09-19

ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01

Applicant Em Diagnostic Systems, Inc.

K number K913922

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JMO 1991-08-12

BIOTROL UIBC REAGENT

Applicant Biotrol, USA, Inc.

K number K912795

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JMO 1990-09-27

IRON 5 X CONC REAGENT

Applicant Trace Scientific , Ltd.

K number K904116

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JMO 1990-05-31

IRON REAGENTS PRODUCT CODES 7725 AND 7726

Applicant American Research Products Co.

K number K901960

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JMO 1989-07-20

J&S IRON SATURATING REAGENTS

Applicant J.S. Medical Assoc.

K number K893662

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JMO 1988-10-25

CHEM 1 UIBC (IRON BINDING CAPACITY TEST)

Applicant Technicon Instruments Corp.

K number K883104

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JMO 1988-07-08

UNSATURATED IRON BINDING CAPACITY

Applicant Data Medical Associates, Inc.

K number K881761

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JMO 1988-03-24

TOTAL IRON BINDING CAPACITY (TIBC)

Applicant Boehringer Mannheim Corp.

K number K880546

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JMO 1987-10-28

IRON REAGENT

Applicant Trace Scientific , Ltd.

K number K874055

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JMO 1987-04-23

EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93

Applicant Em Diagnostic Systems, Inc.

K number K871414

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JMO 1986-09-16

AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241

Applicant American Research Products Co.

K number K863426

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JMO 1985-05-24

TDX REA IRON/TIBC

Applicant Abbott Laboratories

K number K851930

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JMO 1985-05-07

SANDARE IRON-BINDING CAPACITY PROCEDURE

Applicant Sandare Chemical Co., Inc.

K number K851395

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JMO 1985-02-01

SYSTE MATE TIBC HEM NO. 67225

Applicant Em Diagnostic Systems, Inc.

K number K850128

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JMO 1983-10-14

TOTAL IRON-BINDING CAPACITY ACCESORY

Applicant Seragen Diagnostics, Inc.

K number K832759

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JMO 1983-05-25

SERUM UIBC-PTF-600 METHOD

Applicant American Monitor Corp.

K number K831202

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JMO 1978-02-13

IRON BINDING CAPACITY CHEMISTRY

Applicant Harleco

K number K780094

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JMO 1977-11-14

IRON SET, ITEM NO. 65008

Applicant Harleco

K number K771927

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JMO 1977-06-01

TEST, FERROZINE IRON & IRON BINDING

Applicant Hycel, Inc.

K number K770748

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