Product code JMO
- Device name
- Ferrozine (Colorimetric) Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1415
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 |
| K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | Ortho-Clinical Diagnostics, Inc. | 2006-06-15 |
| K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Olympus America, Inc. | 2004-07-16 |
| K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | Wiener Laboratories Saic | 2001-11-13 |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Bayer Corp. | 2001-10-01 |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | 2000-05-02 |
| K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-01-28 |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | 1999-06-30 |
| K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | 1999-05-25 |
| K990216 | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | 1999-02-16 |
| K982041 | UIBC | Abbott Laboratories | 1998-07-30 |
| K981654 | TIBC | Abbott Laboratories | 1998-07-22 |
| K981279 | TIBC | Abbott Laboratories | 1998-05-20 |
| K974604 | RANDOX IRON | Randox Laboratories, Ltd. | 1998-01-06 |
| K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Diagnostic Chemicals , Ltd. | 1996-08-27 |
| K963116 | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | Diagnostic Chemicals , Ltd. | 1996-08-20 |
| K960485 | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | Beckman Instruments, Inc. | 1996-05-10 |
| K955139 | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT | Olympus America, Inc. | 1996-02-12 |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | 1995-05-08 |
| K932517 | IRON/UIBC REAGENT | Sigma Diagnostics, Inc. | 1993-11-09 |
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | King Diagnostics, Inc. | 1993-10-22 |
| K931493 | KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT | Eastman Kodak Company | 1993-05-26 |
| K923569 | PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT | Baxter Diagnostics, Inc. | 1992-08-26 |
| K922784 | SYNERMED UIBC REAGENT KIT | Synermed, Inc. | 1992-07-21 |
| K912716 | J&S IRON REAGENTS | J.S. Medical Assoc. | 1991-09-25 |
| K912717 | J&S UIBC REAGENTS | J.S. Medical Assoc. | 1991-09-25 |
| K913922 | ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 | Em Diagnostic Systems, Inc. | 1991-09-19 |
| K912795 | BIOTROL UIBC REAGENT | Biotrol, USA, Inc. | 1991-08-12 |
| K904116 | IRON 5 X CONC REAGENT | Trace Scientific , Ltd. | 1990-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816426021594 | K-ASSAY® UIBC Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2026-03-13 |
| 10673486001983 | Teco Diagnostics Iron/TIBC Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 06971674869603 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674869610 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674869627 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 05055273209488 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | 2022-09-23 |
| 05055273214727 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | 2022-09-23 |
| 05055273214734 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | 2022-09-23 |
| 00811727015969 | Pointe Direct TIBC Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00811727016263 | Pointe TIBC Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00842768005756 | Dimension® Flex® reagent cartridge IBCT | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768015465 | Dimension Vista® Flex® reagent cartridge TIBC | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414595535 | Atellica CH TIBC | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414474748 | ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 10758750001873 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336121597 | Unsaturated Iron-Binding Capacity | Roche Diagnostics GmbH | 2020-03-05 |
| 05055273206517 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 05055273209426 | IRON (Fe) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 05055273209433 | IRON (Fe) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 05055273209495 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 00816426021396 | K-ASSAY® UIBC Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2019-04-09 |
| 00816426021402 | K-ASSAY® UIBC Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC | 2019-04-09 |
| 00816426021419 | K-ASSAY® UIBC Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC | 2019-04-09 |
| 00386100002190 | Iron (Fe) Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 15099590011925 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 05055273206180 | UIBC | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273206197 | Fe | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 15099590222932 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590228729 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590233365 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |