# K870176: Genetic Systems RSV Immunofluorescence Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Systems Corp.
- Decided: Jul 16, 1987 after 182 days
- Product code: LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa)
- Device class: 1
- Regulation: 21 CFR 866.3480
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 25, 2005 · Not classified · Z-0659-05: New instructions to recommend against using samples with visibly high level of blood.

Source page: https://510kreport.com/device/K870176
Methodology: https://510kreport.com/methodology