# K924096: CMV Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Apr 2, 1993 after 232 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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.
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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093784: Athena Multi-Lyte Torch Igg Plus Test System (2010), 0 descendants of its own

## Recalls of this device
- Jun 18, 2003 · Not classified · Z-1127-03: The Low Positive Standard kit component is losing potency that may result in false positive test results.

Source page: https://510kreport.com/device/K924096
Methodology: https://510kreport.com/methodology