# K911796: Immulite (TM) HCG

- Pathway: 510(k) (Traditional)
- Applicant: Cirrus Diagnostics, Inc.
- Decided: Jun 20, 1991 after 59 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990222: Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6 (1999), 1 descendant of its own
- K042676: Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K911796
Methodology: https://510kreport.com/methodology