# K993952: Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 16, 1999 after 24 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
Longest line of descent: 1 generation back to K950672 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950672: Immulite CMV Igg, Diagnostic Products Corp. (1996) Summary page 1.

## Indications for use
For in vitro use with the IMMULITE® 2000 Automated Analyzer - for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum as an aid in the determination of serological status to CMV. This kit is not cleared for use in testing (i.e. screening) blood or plasma donors.

Source page: https://510kreport.com/device/K993952
Methodology: https://510kreport.com/methodology