# K870814: Herpes Simplex Antibody Test for Dect. of HSV 1&2

- Pathway: 510(k) (Traditional)
- Applicant: Microscan Div. Baxter Healthcare Corp.
- Decided: Jun 4, 1987 after 93 days
- Product code: GQL (Antisera, Fluorescent, 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.
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.

Source page: https://510kreport.com/device/K870814
Methodology: https://510kreport.com/methodology