# K852781: HSV2 - Igg Elisa-Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Sciences, Inc.
- Decided: Jan 21, 1986 after 204 days
- Product code: GQO (Antisera, Cf, Herpesvirus Hominis 1,2)
- Device class: 2
- Regulation: 21 CFR 866.3305
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955362: Incstar HSV I/II Igg Fast Elisa Assay (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K852781
Methodology: https://510kreport.com/methodology