# K944911: Ace Iron Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Feb 10, 1995 after 128 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K113438: Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent (2012), 1 descendant of its own
- K131975: Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L Reagent (2013), 0 descendants of its own
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K944911
Methodology: https://510kreport.com/methodology