# K003754: Immunetics C6 Lyme Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Immunetics, Inc.
- Decided: May 10, 2001 after 156 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- 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
- K062473: Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K003754
Methodology: https://510kreport.com/methodology