# K000463: Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 1, 2000 after 111 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: 1 (0 Class I)
- 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
- K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (2016), 1 descendant of its own
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own
- K041238: Helicobacter Pylori Igg Elisa (2004), 0 descendants of its own

## Recalls of this device
- Jul 31, 2003 · Not classified · Z-1219-03: Kits had parts in them that did not belong in the kit.

Source page: https://510kreport.com/device/K000463
Methodology: https://510kreport.com/methodology