Atlas FDA

JMO

46 FDA 510(k) clearances · Product code

47 daysmedian time to decision
106 days90th percentile
46clearances measured

FDA profile

Official device name
Ferrozine (Colorimetric) Iron Binding Capacity
Device class
Class I (low risk)
Regulation
21 CFR 862.1415
Medical specialty
Clinical Chemistry
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RecordFirmDate
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438)Alfa Wassermann Diagnostic Technologies, Inc.2012-06-01
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464)Ortho-Clinical Diagnostics, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867)Ortho-Clinical Diagnostics, Inc.2005-12-23
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793)Olympus America, Inc.2004-07-16
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102)Wiener Laboratories Saic2001-11-13
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340)Bayer Corp.2001-10-01
DIRECT TIBC KIT (K000781)Reference Diagnostics, Inc.2000-05-02
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115)Dade Behring, Inc.2000-01-28
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244)A.P. Total Care, Inc.1999-05-25
MAGNETIC TIBC KIT (K990216)Reference Diagnostics, Inc.1999-02-16
UIBC (K982041)Abbott Laboratories1998-07-30
TIBC (K981654)Abbott Laboratories1998-07-22
TIBC (K981279)Abbott Laboratories1998-05-20
RANDOX IRON (K974604)Randox Laboratories, Ltd.1998-01-06
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 (K961587)Diagnostic Chemicals , Ltd.1996-08-27
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY (K963116)Diagnostic Chemicals , Ltd.1996-08-20
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS (K960485)Beckman Instruments, Inc.1996-05-10
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT (K955139)Olympus America, Inc.1996-02-12
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (K946354)Data Medical Associates, Inc.1995-05-08
IRON/UIBC REAGENT (K932517)Sigma Diagnostics, Inc.1993-11-09
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (K933329)King Diagnostics, Inc.1993-10-22
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT (K931493)Eastman Kodak Company1993-05-26
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT (K923569)Baxter Diagnostics, Inc.1992-08-26
SYNERMED UIBC REAGENT KIT (K922784)Synermed, Inc.1992-07-21
J&S IRON REAGENTS (K912716)J.S. Medical Assoc.1991-09-25
J&S UIBC REAGENTS (K912717)J.S. Medical Assoc.1991-09-25
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 (K913922)Em Diagnostic Systems, Inc.1991-09-19
BIOTROL UIBC REAGENT (K912795)Biotrol, USA, Inc.1991-08-12
IRON 5 X CONC REAGENT (K904116)Trace Scientific , Ltd.1990-09-27
IRON REAGENTS PRODUCT CODES 7725 AND 7726 (K901960)American Research Products Co.1990-05-31
J&S IRON SATURATING REAGENTS (K893662)J.S. Medical Assoc.1989-07-20
CHEM 1 UIBC (IRON BINDING CAPACITY TEST) (K883104)Technicon Instruments Corp.1988-10-25
UNSATURATED IRON BINDING CAPACITY (K881761)Data Medical Associates, Inc.1988-07-08
TOTAL IRON BINDING CAPACITY (TIBC) (K880546)Boehringer Mannheim Corp.1988-03-24
IRON REAGENT (K874055)Trace Scientific , Ltd.1987-10-28
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 (K871414)Em Diagnostic Systems, Inc.1987-04-23
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 (K863426)American Research Products Co.1986-09-16
TDX REA IRON/TIBC (K851930)Abbott Laboratories1985-05-24
SANDARE IRON-BINDING CAPACITY PROCEDURE (K851395)Sandare Chemical Co., Inc.1985-05-07
SYSTE MATE TIBC HEM NO. 67225 (K850128)Em Diagnostic Systems, Inc.1985-02-01
TOTAL IRON-BINDING CAPACITY ACCESORY (K832759)Seragen Diagnostics, Inc.1983-10-14
SERUM UIBC-PTF-600 METHOD (K831202)American Monitor Corp.1983-05-25
IRON BINDING CAPACITY CHEMISTRY (K780094)Harleco1978-02-13
IRON SET, ITEM NO. 65008 (K771927)Harleco1977-11-14
TEST, FERROZINE IRON & IRON BINDING (K770748)Hycel, Inc.1977-06-01

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