Panels › Clinical Chemistry › Product code JMO · Class 1
Ferrozine (Colorimetric) Iron Binding Capacity
Regulation 862.1415
0510(k)s in 12 months (46 all time)
0recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in JMO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2025 | Beckman Coulter Inc. UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, Open, Classified |
JMO | K041793 |
| Jul 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of tota Open, Classified |
JMO | None listed |
| Aug 18, 2020 | Beckman Coulter Inc. UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding C Terminated |
JMO | K041793 |
| May 24, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD) Terminated |
JMO | K052867 |
| Mar 11, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge.
An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. Terminated |
JMO | K994115 |
| Sep 8, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum Terminated |
JMO | K994115 |
| May 13, 2009 | Diagnostic Chemicals, Ltd. Diagnostics Chemical Limited Iron Assay
Catalog Number: 102-25
For the In Vitro quantitative determination of iron in serum. Terminated |
JMO | K961587 |
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