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.
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| 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 |
Top Applicants
- Abbott Laboratories — 4 clearances
- Em Diagnostic Systems, Inc. — 3 clearances
- J.S. Medical Assoc. — 3 clearances
- A.P. Total Care, Inc. — 2 clearances
- American Research Products Co. — 2 clearances
