# K883767: Lyme Disease Ifa (Igm)

- Pathway: 510(k) (Traditional)
- Applicant: Hillcrest Biologicals
- Decided: Mar 15, 1989 after 190 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
- K971007: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K883767
Methodology: https://510kreport.com/methodology