# K961204: Mumps Igg Test

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 18, 1996 after 113 days
- Product code: LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus)
- Device class: 1
- Regulation: 21 CFR 866.3380
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 8, 2012 · Not classified · Z-1500-2012: Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against M

Source page: https://510kreport.com/device/K961204
Methodology: https://510kreport.com/methodology