# K864882: Ferrozine (Colorimetric) Iron Binding Capacity

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Jan 21, 1987 after 40 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 16, 2009 · Not classified · Z-0899-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0901-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0903-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0906-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0900-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0902-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0905-2010: Turbidity formation could occur, resulting in invalid test results being reported out.
- Nov 16, 2009 · Not classified · Z-0904-2010: Turbidity formation could occur, resulting in invalid test results being reported out.

Source page: https://510kreport.com/device/K864882
Methodology: https://510kreport.com/methodology