JMO · Ferrozine (Colorimetric) Iron Binding Capacity
Clinical Chemistry · 21 CFR 862.1415 · Class 1
Overview
| Product Code | JMO |
|---|---|
| Device Name | Ferrozine (Colorimetric) Iron Binding Capacity |
| Regulation | 21 CFR 862.1415 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (46)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 1, 2012 | SESE |
| K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | Ortho-Clinical Diagnostics, Inc. | Jun 15, 2006 | SESE |
| K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | Dec 23, 2005 | SESE |
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Olympus America, Inc. | Jul 16, 2004 | SESE |
| K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | Wiener Laboratories Saic | Nov 13, 2001 | SESE |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Bayer Corp. | Oct 1, 2001 | SESE |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | May 2, 2000 | SESE |
| K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Jan 28, 2000 | SESE |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | Jun 30, 1999 | SESE |
| K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| K990216 | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | Feb 16, 1999 | SESE |
| K982041 | UIBC | Abbott Laboratories | Jul 30, 1998 | SESE |
| K981654 | TIBC | Abbott Laboratories | Jul 22, 1998 | SESE |
| K981279 | TIBC | Abbott Laboratories | May 20, 1998 | SESE |
| K974604 | RANDOX IRON | Randox Laboratories, Ltd. | Jan 6, 1998 | SESE |
| K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Diagnostic Chemicals , Ltd. | Aug 27, 1996 | SESE |
| K963116 | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | Diagnostic Chemicals , Ltd. | Aug 20, 1996 | SESE |
| K960485 | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | Beckman Instruments, Inc. | May 10, 1996 | SESE |
| K955139 | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT | Olympus America, Inc. | Feb 12, 1996 | SESE |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | May 8, 1995 | SESE |
| K932517 | IRON/UIBC REAGENT | Sigma Diagnostics, Inc. | Nov 9, 1993 | SESE |
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | King Diagnostics, Inc. | Oct 22, 1993 | SESE |
| K931493 | KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT | Eastman Kodak Company | May 26, 1993 | SESE |
| K923569 | PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT | Baxter Diagnostics, Inc. | Aug 26, 1992 | SESE |
| K922784 | SYNERMED UIBC REAGENT KIT | Synermed, Inc. | Jul 21, 1992 | SESE |
| K912717 | J&S UIBC REAGENTS | J.S. Medical Assoc. | Sep 25, 1991 | SESE |
| K912716 | J&S IRON REAGENTS | J.S. Medical Assoc. | Sep 25, 1991 | SESE |
| K913922 | ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 | Em Diagnostic Systems, Inc. | Sep 19, 1991 | SESE |
| K912795 | BIOTROL UIBC REAGENT | Biotrol, USA, Inc. | Aug 12, 1991 | SESE |
| K904116 | IRON 5 X CONC REAGENT | Trace Scientific , Ltd. | Sep 27, 1990 | SESE |
| K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 | American Research Products Co. | May 31, 1990 | SESE |
| K893662 | J&S IRON SATURATING REAGENTS | J.S. Medical Assoc. | Jul 20, 1989 | SESE |
| K883104 | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) | Technicon Instruments Corp. | Oct 25, 1988 | SESE |
| K881761 | UNSATURATED IRON BINDING CAPACITY | Data Medical Associates, Inc. | Jul 8, 1988 | SESE |
| K880546 | TOTAL IRON BINDING CAPACITY (TIBC) | Boehringer Mannheim Corp. | Mar 24, 1988 | SESE |
| K874055 | IRON REAGENT | Trace Scientific , Ltd. | Oct 28, 1987 | SESE |
| K871414 | EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 | Em Diagnostic Systems, Inc. | Apr 23, 1987 | SESE |
| K863426 | AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 | American Research Products Co. | Sep 16, 1986 | SESE |
| K851930 | TDX REA IRON/TIBC | Abbott Laboratories | May 24, 1985 | SESE |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | Sandare Chemical Co., Inc. | May 7, 1985 | SESE |
| K850128 | SYSTE MATE TIBC HEM NO. 67225 | Em Diagnostic Systems, Inc. | Feb 1, 1985 | SESE |
| K832759 | TOTAL IRON-BINDING CAPACITY ACCESORY | Seragen Diagnostics, Inc. | Oct 14, 1983 | SESE |
| K831202 | SERUM UIBC-PTF-600 METHOD | American Monitor Corp. | May 25, 1983 | SESE |
| K780094 | IRON BINDING CAPACITY CHEMISTRY | Harleco | Feb 13, 1978 | SESE |
| K771927 | IRON SET, ITEM NO. 65008 | Harleco | Nov 14, 1977 | SESE |
| K770748 | TEST, FERROZINE IRON & IRON BINDING | Hycel, Inc. | Jun 1, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 4 clearances
- J.S. Medical Assoc. — 3 clearances
- Em Diagnostic Systems, Inc. — 3 clearances
- Trace Scientific , Ltd. — 2 clearances
- Reference Diagnostics, Inc. — 2 clearances
