Panels › Clinical Chemistry › Product code JIY · Class 1
Photometric Method, Iron (Non-Heme)
Regulation 862.1410
0510(k)s in 12 months (67 all time)
1recalls in 12 months (19 all time)
15recalls that name a 510(k)
Top companies in JIY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Iron Deficiency Test Open, Classified |
JIY | None listed |
| Apr 16, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer
Siemens Mater Open, Classified |
JIY | None listed |
| Nov 17, 2023 | Sentinel CH SpA Alinity c Iron Reagent, Reference Number 08P3920 Open, Classified |
JIY | None listed |
| Nov 17, 2023 | Sentinel CH SpA IRON assay, Reference Numbers 6K95-41 and 6K95-30 Open, Classified |
JIY | None listed |
| Jun 28, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative
determination of iron in human serum and (lithium heparin) plasma samples. Open, Classified |
JIY | K991576 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed Terminated |
JIY | K860478 |
| Aug 25, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension IRON Flex reagent cartridges Terminated |
JIY | K060264 |
| Aug 25, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista IRON Flex reagent cartridges Terminated |
JIY | K060264 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547
VITROS Fe Slides quantitatively measure iron (Fe) concentra Terminated |
JIY | K884355 K910143 |
| Dec 3, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)
The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) Terminated |
JIY | K061793 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100. Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL.
Clinical c Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R2.
Clinical chemistry reagent for the quantit Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1.
Clinical chemistry reagent for the quant Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500.
Clinical chemistry reagent for the q Terminated |
JIY | K864882 |
| Mar 2, 2010 | Pointe Scientific, Inc. Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10 Terminated |
JIY | K864882 |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122.
An in-vitro diagnostic reagent system intended for use on COBAS Integra system Terminated |
JIY | K951595 |
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