# K943812: Vidas Lyme Screen II

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Jun 13, 1995 after 312 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- 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
- Oct 28, 2003 · Not classified · Z-0316-04: Kit may contain incorrect components

Source page: https://510kreport.com/device/K943812
Methodology: https://510kreport.com/methodology