# K950672: Immulite CMV Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 17, 1996 after 490 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CYTOMEGELISA II IgG kit: named in the summary without a submission number
- (no number) IMx CMV IgG kit: named in the summary without a submission number

## Most influential descendants
- K993952: Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6 (1999), 0 descendants of its own

## Indications for use
IMMULITE CMV IgG is designed for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to CMV

Source page: https://510kreport.com/device/K950672
Methodology: https://510kreport.com/methodology